Company ยท US
Karl Storz Endoscopy
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2005. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
72recalls (2 in 12 months)
53recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 20 |
| CAL | Laryngoscope, Non-Rigid | 9 |
| FGA | Kit, Nephroscope | 8 |
| GCJ | Laparoscope, General & Plastic Surgery | 6 |
| GWG | Endoscope, Neurological | 6 |
| HRX | Arthroscope | 6 |
| FBO | Cystourethroscope | 5 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 |
| HIH | Hysteroscope (And Accessories) | 4 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 |
| LRC | Instrument, Ent Manual Surgical | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 |
| HWC | Screw, Fixation, Bone | 2 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 |
| CCW | Laryngoscope, Rigid | 1 |
| DQI | Withdrawal/Infusion Pump | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2005 | K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES Karl Storz Endoscopy | ETA |
| Jun 2, 2003 | K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy | HWC |
| Apr 2, 2003 | K030009 | KSEA POWERSHAVER SYSTEM S2 Karl Storz Endoscopy | HRX |
| Feb 21, 2003 | K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR Karl Storz Endoscopy | GEI |
| Dec 2, 2002 | K023187 | KSEA SPINOSCOPE Karl Storz Endoscopy | HRX |
| Aug 16, 2002 | K011700 | MODULITH SLK LITHOTRIPTER Karl Storz Endoscopy | LNS |
| Aug 15, 2002 | K021776 | KSEA QUADRO SWITCH Karl Storz Endoscopy | OCX |
| Feb 26, 2002 | K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX Karl Storz Endoscopy | HWC |
| Sep 10, 2001 | K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR Karl Storz Endoscopy | GCJ |
| Apr 9, 2001 | K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP Karl Storz Endoscopy | GCJ |
| Feb 2, 2001 | K004037 | X-RAY SYSTEM XR-MX Karl Storz Endoscopy | JAA |
| Jul 19, 2000 | K001630 | KSEA BIPOLAR COAGULATING ELECTRODES Karl Storz Endoscopy | GWG |
| Oct 15, 1999 | K992469 | KSEA SCBCOM Karl Storz Endoscopy | FET |
| Sep 9, 1999 | K992027 | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR Karl Storz Endoscopy | HIH |
| Aug 19, 1999 | K992541 | LAPAROCAM Karl Storz Endoscopy | GCJ |
| Aug 18, 1999 | K992114 | KSEA CALCUSPLIT Karl Storz Endoscopy | FFK |
| Jun 23, 1999 | K991228 | DCI ENDOSCOPE Karl Storz Endoscopy | GCJ |
| Jun 23, 1999 | K991171 | DCI ENDOSCOPE Karl Storz Endoscopy | GCJ |
| May 11, 1999 | K990411 | MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE Karl Storz Endoscopy | HIH |
| Dec 7, 1998 | K983142 | KSEA C-MOUNT ARTHROSCOPES Karl Storz Endoscopy | HRX |
| Nov 6, 1998 | K982837 | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS Karl Storz Endoscopy | GWG |
| Oct 5, 1998 | K982905 | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE Karl Storz Endoscopy | FGB |
| Aug 12, 1998 | K981703 | KSEA UNIMAT 45 Karl Storz Endoscopy | BTA |
| May 20, 1998 | K981458 | KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110 Karl Storz Endoscopy | EOB |
| Jan 22, 1998 | K972488 | KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES Karl Storz Endoscopy | HET |
| Jan 8, 1998 | K974366 | KSEA PLASTIC TROCARS Karl Storz Endoscopy | GCJ |
| May 27, 1997 | K963423 | KSEA CO2 ENDOFLATOR Karl Storz Endoscopy | HIF |
| Mar 11, 1997 | K970427 | KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE Karl Storz Endoscopy | FGB |
| Nov 14, 1996 | K963524 | KSEA LARGE JOINT ARTHROSCOPY SET Karl Storz Endoscopy | HRX |
| Oct 25, 1996 | K960486 | KSEA MODEL 383320 20 ANGIOMAT Karl Storz Endoscopy | DQI |
| Oct 22, 1996 | K962881 | KSEA CULDOCENTESIS SET Karl Storz Endoscopy | HEW |
| Aug 25, 1995 | K953109 | HAND EXTRACTOR HECTOR Karl Storz Endoscopy | HIH |
| May 25, 1995 | K943052 | ARTHROSCOPIC TELESCOPES Karl Storz Endoscopy | HRX |
| Feb 28, 1995 | K942112 | KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE Karl Storz Endoscopy | FBN |
| Jan 24, 1995 | K936231 | THE KARL STORZ HAMOU ENDOMAT Karl Storz Endoscopy | HIG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2026 | Karl Storz Endoscopy HOPKINS Telescope 30, 4mm REF 10005BA
UDI-DI code: 04048551045121
KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical site during diagnostic and therapeutic Open, Classified |
EOB | K945788 |
| Jul 23, 2026 | Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. Open, Classified |
HIH | K961605 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE Open, Classified |
FGB | K233372 |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 Open, Classified |
FGB | K233372 |
| Jan 10, 2025 | Karl Storz Endoscopy Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Open, Classified |
LRC | None listed |
| Nov 25, 2024 | Karl Storz Endoscopy 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x
3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x
5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x
5.5 x 120 mm R Open, Classified |
HRX | K030009 |
| Nov 12, 2024 | Karl Storz Endoscopy Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10
Tubing Set, Irrigation, PC Open, Classified |
NVT | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | K232370 |
| May 13, 2024 | Karl Storz Endoscopy LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 Open, Classified |
GEX | K942786 |
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only Open, Classified |
LRC | None listed |
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE Open, Classified |
HET | K951343 |
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only Open, Classified |
EOQ | K954797 |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D Open, Classified |
CCW | None listed |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, 13 cm, REF: 738756; Injection Needle, angular, 13 cm, REF: 7387 Open, Classified |
LRC | None listed |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, LUER-lock,0.8mm, REF: 26175PD Open, Classified |
HET | K951190 |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A Open, Classified |
FBK | K950976 |
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, REF: 25207 Open, Classified |
GCF | K945209 |
| Sep 15, 2023 | Karl Storz Endoscopy Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Open, Classified |
EOQ | K212656 |
| Jun 21, 2023 | Karl Storz Endoscopy Metal Tray, 178 x 135 x 37 mm, REF: 11580A;
Metal Tray, 275 x 178 x 35 mm, REF: 11580B;
Metal Tray, 373 x 178 x 35 mm, REF: 11580C;
Metal Tray, 275 x 175 x 37 mm, REF: 11580D;
Wire Tray f. Cleaning, 2 Open, Classified |
KCT | K203198 |
| Jun 21, 2023 | Karl Storz Endoscopy KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A Open, Classified |
KCT | K203572 |
| May 3, 2022 | Karl Storz Endoscopy STORZ KARL STORZ-ENDOSKOPE
REF 11272VUE CMOS Video Cysto-Urethroscope
REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT
REF 11272VUE-R CMOS Video Cysto-Urethroscope
REF 11272VUEK-R CMOS Video C Open, Classified |
FAJ | K202957 |
| Apr 1, 2022 | Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSU 11278VSUK Flexible Vi Open, Classified |
FGB | K141250 |
| Apr 1, 2022 | Karl Storz Endoscopy 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VSU 11278VSUK Flexible Vi Open, Classified |
FGB | K141250 |
| Apr 1, 2022 | Karl Storz Endoscopy 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016);
11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020);
11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX- Open, Classified |
FGB | K131369 |
| Apr 1, 2022 | Karl Storz Endoscopy 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018);
11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);
11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018);
11278ACU1 11278AC Open, Classified |
FGB | K982905 |
| Apr 1, 2022 | Karl Storz Endoscopy 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018) Open, Classified |
FAJ | K082046 |
| Apr 1, 2022 | Karl Storz Endoscopy 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021);
11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) Open, Classified |
FBO | K202957 |
| Apr 1, 2022 | Karl Storz Endoscopy 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) Open, Classified |
EOQ | K212656 |
| Apr 1, 2022 | Karl Storz Endoscopy 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) Open, Classified |
EOB | K171402 |
| Apr 1, 2022 | Karl Storz Endoscopy 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018);
11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018) Open, Classified |
FBO | K062918 |
| Apr 1, 2022 | Karl Storz Endoscopy 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021)
11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) Open, Classified |
FBO | K212476 |
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