# Visionsense, Ltd.

- Location (FDA's records): Petach Tikva, Hamerkaz, IL
- FDA decisions: 13 (2008–2022): 13 510(k) clearances
- Product codes: OWN (4), HRX (3), GCJ (2), GWG (2), FED (1), EOB (1)
- 510(k) review time since 2016: median 180 days, against 97 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 30 (18 its own); citations of its devices by later devices: 23 (18 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic, Inc.: 4 (https://510kreport.com/company/medtronic)
- Novadaq Technologies, Inc.: 2 (https://510kreport.com/company/novadaq-technologies)
- Envision Advanced Medical System, Ltd.: 1 (https://510kreport.com/company/envision-advanced-medical-system)
- Karl Storz Endoscopy: 1 (https://510kreport.com/company/karl-storz-endoscopy)
- Asap Endoscopic Products GmbH: 1 (https://510kreport.com/company/asap-endoscopic-products)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Joimax GmbH: 1 (https://510kreport.com/company/joimax)
- Vista Medical Technologies, Inc.: 1 (https://510kreport.com/company/vista-medical-technologies)

## Firms that cite its devices most
- KARL STORZ Endoscopy-America, Inc.: 3 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Surgvision GmbH: 1 (https://510kreport.com/company/surgvision)
- Mauna Kea Technologies: 1 (https://510kreport.com/company/mauna-kea-technologies)

## Its most-cited devices
- K073279: VS-Visionsense Stereoscopic Vision System (2008), cited by 4
- K081102: Vsu - Visionsense Stereoscopic Vision System (2008), cited by 3
- K131434: VS3 Stereoscopic High Definition Vision System (2013), cited by 3
- K210265: VS3 Iridium Sytem (2021), cited by 3
- K150018: VS3-IR-MMS System (2015), cited by 2
- K152204: VS3-IR system (2015), cited by 2

## Recent decisions
- K223020: VS3-Iridium System (VS3-IR) (Oct 28, 2022)
- K210265: VS3 Iridium Sytem (Nov 22, 2021)
- K171208: Trans-anal Introducer (Feb 5, 2018)
- K153548: VS3 Stereoscopic High Definition Vision System (Feb 22, 2016)
- K152204: VS3-IR system (Oct 28, 2015)
- K150018: VS3-IR-MMS System (Jun 17, 2015)
- K141002: VS3 Stereoscopic High Definition Vision System (Jun 26, 2014)
- K131434: VS3 Stereoscopic High Definition Vision System (Jul 16, 2013)

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