Company · US
Gyrus Acmi, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (1 in 12 months)
33recalls (0 in 12 months)
28recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 41 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 4 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 |
| FAS | Electrode, Electrosurgical, Active, Urological | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 |
| ETD | Tube, Tympanostomy | 2 |
| GEX | Powered Laser Surgical Instrument | 2 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 |
| EQJ | Bur, Ear, Nose And Throat | 1 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 |
| FGA | Kit, Nephroscope | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| HHI | System, Abortion, Vacuum | 1 |
| HIG | Insufflator, Hysteroscopic | 1 |
| HIH | Hysteroscope (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 2026 | K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) Gyrus Acmi, Inc. | GEI |
| Mar 25, 2024 | K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Revers Gyrus Acmi, Inc. | FGB |
| Oct 25, 2023 | K231327 | POWERSEAL Sealer and Divider Gyrus Acmi, Inc. | GEI |
| Jan 27, 2023 | K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories Gyrus Acmi, Inc. | GEX |
| Jan 19, 2022 | K212650 | Celeris, Disposable Sinus Debrider Gyrus Acmi, Inc. | ERL |
| Jan 4, 2022 | K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle Gyrus Acmi, Inc. | GEI |
| Jun 3, 2021 | K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Access Gyrus Acmi, Inc. | GEX |
| Nov 30, 2018 | K181696 | ChitoZolve Gyrus Acmi, Inc. | LYA |
| Mar 8, 2018 | K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter Gyrus Acmi, Inc. | FGE |
| Sep 29, 2017 | K171440 | Berkeley VC-10 Vacuum Curettage System Gyrus Acmi | HHI |
| May 19, 2017 | K170908 | PK AIM Gyrus Acmi, Inc. | GEI |
| Dec 12, 2016 | K163373 | PK AIM Gyrus Acmi, Inc. | GEI |
| Oct 7, 2016 | K161038 | PK Morcellator Gyrus Acmi, Inc. | GEI |
| Sep 26, 2016 | K161825 | PK AIM Gyrus Acmi, Inc. | GEI |
| Jun 10, 2016 | K152744 | DIEGO ELITE DRILL Gyrus Acmi, Inc. | ERL |
| Jan 15, 2016 | K152531 | InstaClear Lens Cleaner Gyrus Acmi, Inc. | EOB |
| Dec 17, 2015 | K152219 | PK AIM Gyrus Acmi, Inc. | GEI |
| Jan 13, 2015 | K142759 | PK Cutting Forceps for ESG-400 Workstation Gyrus Acmi, Inc. | GEI |
| Jan 8, 2015 | K142350 | PK J-HOOK Gyrus Acmi, Inc. | GEI |
| Dec 31, 2014 | K142289 | PK Spatula Gyrus Acmi, Inc. | GEI |
| Dec 19, 2014 | K142154 | PK NEEDLE Gyrus Acmi, Inc. | GEI |
| Feb 4, 2014 | K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER Gyrus Acmi, Inc. | LJE |
| Apr 5, 2013 | K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) Gyrus Acmi, Inc. | GEI |
| Dec 5, 2012 | K122605 | PKS BILL Gyrus Acmi, Inc. | HIN |
| Aug 30, 2012 | K121678 | DTAD Gyrus Acmi, Inc. | ERL |
| Jul 10, 2012 | K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY Gyrus Acmi, Inc. | KCT |
| Jun 20, 2012 | K120567 | GYRUS AMCI PK BUTTON ELECTRODE Gyrus Acmi, Inc. | FAS |
| Sep 1, 2011 | K111059 | GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) Gyrus Acmi, Inc. | HIN |
| Jul 19, 2011 | K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM Gyrus Acmi, Inc. | HIG |
| May 20, 2011 | K102970 | GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT Gyrus Acmi, Inc. | KCT |
| Oct 20, 2010 | K092571 | GYRUS ACMI BIOCOAG PROBE Gyrus Acmi, Inc. | KNS |
| Jul 1, 2010 | K100816 | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 Gyrus Acmi, Inc. | GEI |
| Jun 17, 2010 | K100896 | GYRUS ACMI HALO PKS CUTTING FORCEPS Gyrus Acmi, Inc. | GEI |
| Feb 24, 2010 | K093181 | GYRUS ACMI PK BUTTON ELECTRODE Gyrus Acmi, Inc. | FAS |
| Dec 11, 2009 | K092682 | GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS Gyrus Acmi, Inc. | KCT |
| Sep 29, 2009 | K092278 | GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 Gyrus Acmi, Inc. | HIH |
| Aug 13, 2009 | K080844 | G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE Gyrus Acmi, Inc. | GEI |
| Apr 20, 2009 | K090814 | MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 Gyrus Acmi, Inc. | FAJ |
| Dec 9, 2008 | K083013 | PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 Gyrus Acmi, Inc. | GEI |
| Aug 8, 2008 | K081766 | PKS OMNI INSTRUMENT Gyrus-Acmi L.P. | GEI |
| Aug 6, 2008 | K082054 | GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003 Gyrus Acmi, Inc. | GEI |
| Jul 31, 2008 | K081954 | GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE Gyrus Acmi, Inc. | GEI |
| May 2, 2008 | K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK Gyrus Acmi, Inc. | GEI |
| Dec 13, 2007 | K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM Gyrus Acmi, Inc. | FGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Malleable, 4mm Standard Monopolar Blades
Product Code:MM4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Blades Monopolar, 4mm Straight, TIA
Product Code:MB4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040XC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040SC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number:BB4040SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part No: BB4000SC Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part Number: BB4000SS Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A
Part No BB2000SA Terminated |
GEI | K123429 |
| Mar 8, 2019 | Gyrus ACMI, Inc. Olympus Diego Elite Console
MDCONS 100 Terminated |
GEI | K123429 |
| Apr 17, 2018 | Gyrus Acmi, Incorporated Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700)
The cord consists of a single conductor stranded wire terminated with plugs that connect to a gen Terminated |
FAS | K890328 |
| Mar 20, 2018 | Gyrus ACMI, Inc. Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system Open, Classified |
EQJ | None listed |
| Jun 26, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a st Terminated |
KNH | None listed |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | K123429 |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | K123429 |
| May 31, 2013 | Gyrus Acmi, Incorporated GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104
Disposable myringotomy knife int Terminated |
LRC | None listed |
| Nov 20, 2012 | Gyrus Acmi, Incorporated PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC.,
Tympanostomy tube Terminated |
ETD | None listed |
| May 26, 2011 | Gyrus Acmi, Incorporated Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA
Ureteral guidewires are used Terminated |
KNY | None listed |
| Sep 30, 2010 | Gyrus Acmi, Incorporated GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS ME Terminated |
GEI | K041285 |
| Sep 19, 2010 | Gyrus Acmi, Incorporated The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) Terminated |
GCJ | K923945 |
| Mar 4, 2010 | Gyrus ACMI Corporation MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA.
Intended to be implanted for ventilation or draina Terminated |
ETD | K820362 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sout Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, S Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Sou Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requ Terminated |
GEI | K024286 |
| Jan 14, 2010 | Gyrus ACMI Corporation Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.61 or greater requir Terminated |
GEI | K024286 |
| Nov 5, 2008 | Gyrus ACMI Corporation Gyrus ACMI, Inc. dissector PlasmaKnife (DPK)
Catalog No: 7035-3005
A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery with Terminated |
GEI | K041285 |
| Sep 16, 2008 | Gyrus ACMI Corporation Gyrus ACMI 10 Fr. Dual Lumen Catheter
Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, Terminated |
EYB | K043581 |
| Aug 9, 2007 | Gyrus ACMI Corporation Gyrus CyberWand Ultrasonic Lithotripter System includes:
CW-USLS CyberWand USL System
CW-USLT CyberWand USL Transducer
CW-USLRBP CyberWand USL Renal/Bladder Probe Set
CW-USLTT CyberWand USL Transduce Terminated |
FFK | K052135 |
| Mar 13, 2007 | Gyrus ACMI Corporation Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903 Terminated |
KNS | K932293 |
| Mar 13, 2007 | Gyrus ACMI Corporation Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901 Terminated |
KNS | K932293 |
| Mar 13, 2007 | Gyrus ACMI Corporation Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 Terminated |
KNS | K932293 |