# SmartsurgN, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 3 (2022–2026): 3 510(k) clearances
- Names in FDA's records: SmartsurgN, Inc. (2); Smartsurgn Incorporated (1)
- Product codes: OWN (2), HIF (1)
- 510(k) review time since 2016: median 347 days, against 63 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Intuitive Surgical, Inc.: 1 (https://510kreport.com/company/intuitive-surgical)

## Its most-cited devices
- K213943: SmartSurgN Visualization System (2022), cited by 1

## Recent decisions
- K242163: SmartSurgN Visualization System (Apr 20, 2026)
- K242772: AirSurgN Insufflator (10030/AirSurgN) (Apr 11, 2025)
- K213943: SmartSurgN Visualization System (Nov 29, 2022)

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