# Genicon, Inc.

- Location (FDA's records): Winter Park, FL
- FDA decisions: 11 (2004–2019): 11 510(k) clearances
- Names in FDA's records: Genicon, Inc. (6); Genicon (5)
- Product codes: GCJ (6), GEI (4), FZP (1)
- 510(k) review time since 2016: median 45 days, against 88 for FDA's reviews in the same codes and years (5 of 6 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Endoscopy: 2 (https://510kreport.com/company/stryker-endoscopy)
- Anchor Products Co.: 2 (https://510kreport.com/company/anchor-products)
- Espiner Medical Limited: 1 (https://510kreport.com/company/espiner-medical)
- PAJUNK GmbH Medizintechnologie: 1 (https://510kreport.com/company/pajunk-medizintechnologie)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)

## Firms that cite its devices most
- Dannik: 1 (https://510kreport.com/company/dannik)
- Thermedx, LLC: 1 (https://510kreport.com/company/thermedx)
- Ackermann Instrumente GmbH: 1 (https://510kreport.com/company/ackermann-instrumente)
- Well Lead Medical Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical)
- Ximedica: 1 (https://510kreport.com/company/ximedica)
- Qingdao Kingston Medical Devices, Ltd.: 1 (https://510kreport.com/company/qingdao-kingston-medical-devices)
- Unimax Medical Systems, Inc.: 1 (https://510kreport.com/company/unimax-medical-systems)

## Its most-cited devices
- K132375: Genistrong Single-Use Specimen Retrieval Bag (2014), cited by 3
- K061417: Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910 (2006), cited by 3
- K162059: Ezee Retrieval (2016), cited by 1
- K100090: Implantable Clip (2010), cited by 1
- K180836: Genistrong (2018), cited by 1
- K041967: Genicon Suction Irrigation System (2004), cited by 1

## Recent decisions
- K190168: Aquas Probes (Mar 14, 2019)
- K181791: Simplystrong, Simplyezee (Aug 21, 2018)
- K180836: Genistrong (Apr 18, 2018)
- K180579: Ezee Retrieval (Mar 19, 2018)
- K171752: X-Surge (Oct 17, 2017)
- K162059: Ezee Retrieval (Sep 29, 2016)
- K132375: Genistrong Single-Use Specimen Retrieval Bag (Jun 12, 2014)
- K100090: Implantable Clip (Feb 2, 2010)

Source page: https://510kreport.com/company/genicon