Company · US
Aesculap, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2026. Name variants (Inc, Corp, punctuation) are merged.
219510(k) clearances (1 in 12 months)
46recalls (1 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 23 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 20 |
| JXG | Shunt, Central Nervous System And Components | 20 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 13 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 11 |
| HCH | Clip, Aneurysm | 10 |
| GWG | Endoscope, Neurological | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 8 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 7 |
| HCI | Applier, Aneurysm Clip | 7 |
| FRG | Wrap, Sterilization | 6 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 5 |
| FZP | Clip, Implantable | 4 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 4 |
| HBB | Motor, Drill, Pneumatic | 4 |
| HBC | Motor, Drill, Electric | 4 |
| HWC | Screw, Fixation, Bone | 4 |
| LRZ | Screwdriver, Surgical | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 4 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K260044 | Ventricular Catheters, Thomale Catheter Aesculap, Inc. | JXG |
| May 13, 2025 | K242762 | Aesculap Aicon® Series Container System Aesculap, Inc. | KCT |
| Dec 16, 2024 | K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set Aesculap, Inc. | JXG |
| Jun 29, 2023 | K223596 | SQ.line KERRISON Aesculap, Inc. | HAE |
| Dec 30, 2022 | K214041 | Aesculap AICON Container Aesculap, Inc. | KCT |
| Dec 13, 2021 | K211572 | Aesculap Slim Clip Applier Aesculap, Inc. | HCI |
| Aug 24, 2021 | K203739 | ELAN 4 Electro Motor System Aesculap, Inc. | HBE |
| Jan 21, 2021 | K202391 | DIR 800 Aesculap, Inc. | IZI |
| Dec 18, 2020 | K203461 | Aesculap Caiman 12 Seal and Cut Technology System Aesculap, Inc. | GEI |
| Oct 30, 2020 | K202938 | Aesculap Caiman 5 Seal and Cut Technology System Aesculap, Inc. | GEI |
| Sep 2, 2020 | K202124 | Aesculap PAS-Port Proximal Anastomosis System Aesculap, Inc. | FZP |
| May 8, 2020 | K200950 | Ventricular Catheter Aesculap, Inc. | JXG |
| Mar 27, 2020 | K192056 | JJ Series Container System Aesculap, Inc. | KCT |
| Mar 17, 2020 | K193582 | SterilContainer S2 System Aesculap, Inc. | KCT |
| Nov 21, 2019 | K192266 | M. Blue Adjustable Shunt System Aesculap, Inc. | JXG |
| Aug 9, 2019 | K183203 | ELAN 4 Tools Aesculap, Inc. | HBE |
| Jul 5, 2019 | K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves Aesculap, Inc. | JXG |
| Jul 5, 2019 | K182414 | Aesculap® SterilContainer(TM) S2 System Aesculap, Inc. | KCT |
| Mar 12, 2019 | K183180 | Caiman 5 Maryland Aesculap, Inc. | GEI |
| Jan 19, 2019 | K182527 | ELAN 4 Tools Aesculap, Inc. | HBE |
| Dec 21, 2018 | K182032 | SterilContainer S System Aesculap, Inc. | KCT |
| Nov 9, 2018 | K172907 | ELAN 4 Air Motor System Aesculap, Inc. | HBB |
| Oct 17, 2018 | K172709 | ELAN 4 Electro Motor System Tools Aesculap, Inc. | HBE |
| Apr 17, 2018 | K180914 | Aesculap Slim Clip Applier Aesculap, Inc. | HCI |
| Mar 7, 2018 | K180321 | Aesculap Optilene Nonabsorbable Suture Aesculap, Inc. | GAW |
| Feb 20, 2018 | K170683 | Aesculap Video Assisted Thoracic Surgery (VATS) INstruments Aesculap, Inc. | GCJ |
| Nov 17, 2017 | K172850 | SterilContainer with PrimeLine Pro Lid Aesculap, Inc. | KCT |
| Nov 10, 2017 | K173271 | Aesculap Slim Clip Applier Forceps Aesculap, Inc. | HCI |
| Oct 23, 2017 | K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture Aesculap, Inc. | GAM |
| Jul 13, 2017 | K162815 | SterilContainer S System Aesculap, Inc. | KCT |
| Jun 8, 2017 | K170661 | Novosyn Quick Absorbable Suture Aesculap, Inc. | GAM |
| Feb 27, 2017 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System Aesculap, Inc. | JXG |
| Jul 22, 2016 | K152960 | ELAN 4 Motor System Aesculap, Inc. | HBC |
| May 26, 2016 | K160393 | AdTec Aesculap, Inc. | GCJ |
| Feb 17, 2016 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture Aesculap, Inc. | GAR |
| Oct 27, 2015 | K151865 | PremiPatch PTFE Pledget Aesculap, Inc. | DXZ |
| Oct 9, 2015 | K151242 | SterilContainer S Aesculap, Inc. | KCT |
| Aug 18, 2015 | K143729 | SterilContainer S Aesculap, Inc. | KCT |
| Jul 21, 2015 | K151858 | Caiman Seal and Cut Technology Aesculap, Inc. | GEI |
| Jul 20, 2015 | K151696 | Caiman Seal and Cut Technology Aesculap, Inc. | GEI |
| Jul 8, 2015 | K142970 | SterilContainer S System Aesculap, Inc. | KCT |
| Apr 2, 2015 | K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM Aesculap, Inc. | JXG |
| Nov 14, 2014 | K142315 | MINOP Disposable Introducer 26F Aesculap, Inc. | GWG |
| Jul 15, 2014 | K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE Aesculap, Inc. | GAW |
| May 13, 2014 | K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP Aesculap, Inc. | MPN |
| Apr 28, 2014 | K140839 | CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. | GEI |
| Jan 24, 2014 | K131500 | YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS Aesculap, Inc. | HCH |
| Jun 4, 2013 | K122791 | LYOPLANT ONLAY Aesculap, Inc. | GXQ |
| May 17, 2013 | K121976 | AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE Aesculap, Inc. | MPN |
| Mar 22, 2013 | K130596 | CAIMAN SEAL AND CUT TECHNOLOGY Aesculap, Inc. | GEI |
Newest 50 of 219.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2026 | Aesculap Inc Brand Name: AESCULAP
Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM
Model/Catalog Number: FF399R
Software Version: N/A
Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM
Component: N/ Open, Classified |
GWG | K983365 |
| Oct 24, 2025 | Aesculap Inc Brand Name: AESCULAP
Product Name: REDUCING CONVERTER 10/12MM TO 5MM
Model/Catalog Number: EK087P
Software Version: N/A
Product Description: REDUCING CONVERTER 10/12MM TO 5MM
Component: N/A Open, Classified |
GCJ | None listed |
| Oct 24, 2025 | Aesculap Inc Brand Name: AESCULAP
Product Name: SEALING UNIT FOR 10/12MM TROCARS
Model/Catalog Number: EK086P
Software Version: N/A
Product Description: SEALING UNIT FOR 10/12MM TROCARS
Component: N/A Open, Classified |
GCJ | None listed |
| Oct 24, 2025 | Aesculap Inc Brand Name: Aesculap
Product Name: SEALING CAP FOR 10/12MM TROCARS
Model/Catalog Number: EK085P
Software Version: N/A
Product Description: SEALING CAP FOR 10/12MM TROCARS
Component: N/A Open, Classified |
GCJ | None listed |
| Oct 24, 2025 | Aesculap Inc Brand Name: Aesculap
Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER
Model/Catalog Number: EK083P
Software Version: N/A
Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER
Component: Open, Classified |
GCJ | None listed |
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. Open, Classified |
HBB | K172907 |
| Oct 2, 2025 | Aesculap AG AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. Open, Classified |
HBB | K172907 |
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM;
(2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM;
(3) REF BH957R, Schnidt Tonsil Forceps SLT-C Open, Classified |
KAE | None listed |
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF FB458R, Glover ATR.CLAMP CVD 215MM;
(2) REF FB459R, Glover ATR.CLAMP CVD 245MM;
(3) REF FB461R, Glover ATR.CLAMP 195MM;
(4) REF FB462R, Glov Open, Classified |
HXD | None listed |
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF BH198R, Fuchsig Artery Forceps CVD.190MM;
(2) REF BH304R, Pean Artery Forceps Straight 140MM;
(3) REF BH813R, Artery Forceps Curved 250MM;
(4 Open, Classified |
HTD | None listed |
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF BH100R, Carrel Artery Forceps 85MM;
(2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM;
(3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM;
(4) Open, Classified |
HRQ | None listed |
| Mar 11, 2025 | Aesculap Inc Numerous models of nonsterile hemostatic forceps:
(1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM;
(2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM;
(3) REF BJ511R, Holzbach Hyst Forceps Open, Classified |
HGC | None listed |
| Jun 12, 2024 | Aesculap Inc Aeos Robotic Digital Microscope, Product Code: PV010 Open, Classified |
FSO | None listed |
| Mar 1, 2024 | Aesculap Inc DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures. Open, Classified |
GCJ | K101937 |
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures. Open, Classified |
GCJ | K101937 |
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures. Open, Classified |
GCJ | K101937 |
| Mar 1, 2024 | Aesculap Inc DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. Open, Classified |
GCJ | K101937 |
| Mar 1, 2024 | Aesculap Inc DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. Open, Classified |
GCJ | K101937 |
| Jan 31, 2024 | Aesculap Inc MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM" Open, Classified |
HCF | None listed |
| Jan 31, 2024 | Aesculap Inc MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"; Open, Classified |
HCF | None listed |
| Dec 16, 2015 | Aesculap, Inc. Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed.
These instr Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Drill;
SJ723R; NON STERILE;
B Braun Aesculap;
Aesculap AG
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Bone Awl;
SJ607R; NON STERILE;
B Braun Aesculap;
Aesculap AG:
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Dec 16, 2015 | Aesculap, Inc. Flexible Screw Driver SJ706R;
Non Sterile;
B Braun;
Aesculap;
Aesculap AG
These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Terminated |
LRZ | None listed |
| Nov 30, 2015 | Aesculap, Inc. Columbus Revision Knee System, EnduRo Knee System
Product Usage:
The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. Terminated |
JWH | K083772 |
| Nov 17, 2015 | Aesculap, Inc. Valve XS Atrium Retractor
FC429R
52154756
The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and Terminated |
GAD | None listed |
| Aug 3, 2015 | Aesculap, Inc. S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipita Terminated |
HXC | None listed |
| Jan 26, 2015 | Aesculap, Inc. Miethke Shunt System accessories
Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. Terminated |
JXG | K120559 |
| Dec 16, 2014 | Aesculap, Inc. Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Terminated |
JXG | K110206 |
| Dec 3, 2014 | Aesculap, Inc. The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus. Terminated |
JXG | K011030 |
| Jul 9, 2014 | Aesculap, Inc. Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding Terminated |
GAR | K990090 |
| Jun 2, 2014 | Aesculap, Inc. Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System
The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the Terminated |
JXG | K031303 |
| Feb 19, 2014 | Aesculap, Inc. Aesculap proSA Adjustment Disc Size Large (L)
The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. Terminated |
JXG | K120559 |
| Jan 3, 2014 | Aesculap, Inc. Aesculap Hi-Line XXS handpiece
Hi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone. Terminated |
GET | None listed |
| Dec 13, 2013 | Aesculap, Inc. Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 Terminated |
JWH | K083772 K122985 |
| Dec 11, 2013 | Aesculap, Inc. Aesculap GNI161 Bipolar Foot Control
Product Usage:
The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used i Terminated |
GEI | K952524 |
| Nov 19, 2013 | Aesculap, Inc. Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) Terminated |
LXH | None listed |
| Oct 21, 2013 | Aesculap, Inc. UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. Terminated |
GAD | None listed |
| Jul 25, 2013 | Aesculap, Inc. ProSpace Peek Implant 5 degree x 8.5 x 22 mm
The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Terminated |
MAX | K071983 |
| Feb 26, 2013 | Aesculap, Inc. Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation. Terminated |
GEI | None listed |
| Feb 12, 2013 | Aesculap, Inc. Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide
Central Nervous System Shunt and Components intended to shu Terminated |
JXG | K020728 K110206 |
| Oct 18, 2012 | Aesculap, Inc. Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) Terminated |
LXH | None listed |
| Aug 12, 2011 | Aesculap Inc Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems.
Aesculap AG.
Intended to replace a hip joint Terminated |
LZO | K071916 |
| Mar 2, 2011 | Aesculap Inc Aesculap MicroSpeed Uni Control Box, Part #GD670
Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surger Terminated |
HBC | K053526 |
| Jan 29, 2008 | Aesculap Inc Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034 Terminated |
HCI | K940970 |
| Jan 29, 2008 | Aesculap Inc Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034 Terminated |
HCI | K940970 |