# KARL STORZ Endoscopy-America, Inc.

- Location (FDA's records): Culver City, CA
- FDA decisions: 370 (1980–2026): 367 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: KARL STORZ Endoscopy-America, Inc. (337); Karl Storz Endoscopy America, Inc. (25); Karl Storz Endoscopy America (5); Karl Storz-Endoscopy-America, Inc. (2); Karl Storz Endoscopy_America, Inc. (1)
- Product codes: GCJ (51), HET (29), HRX (28), EOB (28), EOQ (13), GEI (13), FET (13), HIH (11), GWG (10), HIF (9), FAJ (8), FGB (7)
- 510(k) review time since 2016: median 133 days, against 126 for FDA's reviews in the same codes and years (18 of 37 faster)
- Predicates its devices cite: 127 (65 its own); citations of its devices by later devices: 218 (65 its own)
- Recalls linked to its devices: 43 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Karl Storz Endoscopy: 6 (https://510kreport.com/company/karl-storz-endoscopy)
- Symmetry Medical: 3 (https://510kreport.com/company/symmetry-medical)
- Visionsense, Ltd.: 3 (https://510kreport.com/company/visionsense)
- Karl Storz Imaging, Inc.: 3 (https://510kreport.com/company/karl-storz-imaging)
- Acmi Corporation: 2 (https://510kreport.com/company/acmi)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Olympus Optical Co., Ltd.: 2 (https://510kreport.com/company/olympus-optical)
- Electro Medical Systems SA: 2 (https://510kreport.com/company/electro-medical-systems)

## Firms that cite its devices most
- Karl Storz SE & CO. KG: 26 (https://510kreport.com/company/karl-storz)
- Richard Wolf Medical Instruments Corp.: 8 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Zhuhai Pusen Medical Technology Co., Ltd.: 3 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- Sialo Technology, Ltd.: 3 (https://510kreport.com/company/sialo-technology)
- World of Medicine Lemke GmbH: 3 (https://510kreport.com/company/world-of-medicine-lemke)
- Acclarent, Inc.: 3 (https://510kreport.com/company/acclarent)
- Gimmi GmbH: 3 (https://510kreport.com/company/gimmi)

## Its most-cited devices
- K012527: Ksea Sialoendoscopes and Accessories (2001), cited by 6
- K103467: Cmos Video Rhino-Laryngoscope System Model 11101CM (2012), cited by 6
- K071530: Karl Storz Video Flexible Video Ent Endoscope System (2007), cited by 5
- K131369: Flexible Video-Uretero-Renoscope System (2013), cited by 5
- K962595: Karl Storz Xenon 300 Light Source for Non-Flash Applications (1996), cited by 5
- K935279: Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope (1994), cited by 5

## Recent decisions
- K252624: KARL STORZ Laryngoscopes and Accessories (May 15, 2026)
- K240506: KARL STORZ Holders (Oct 22, 2024)
- K223885: HOPKINS Telescopes (Sep 14, 2023)
- K230359: KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- (Jun 23, 2023)
- K223520: UNIDRIVE SIII System (Apr 27, 2023)
- K223923: HOPKINS Telescopes (Mar 30, 2023)
- K221893: KARL STORZ Bipolar Resectoscopes with HF Cable (Mar 17, 2023)
- K221004: HOPKINS Telescopes (Dec 20, 2022)

Source page: https://510kreport.com/company/karl-storz-endoscopy-america