# Asensus Surgical, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Names in FDA's records: Asensus Surgical, Inc. (5); Asensus Surgical (1)
- Product codes: NAY (6)
- 510(k) review time since 2016: median 114 days, against 75 for FDA's reviews in the same codes and years (0 of 6 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Intuitive Surgical, Inc.: 2 (https://510kreport.com/company/intuitive-surgical)
- Transenterix, Inc.: 2 (https://510kreport.com/company/transenterix)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)

## Its most-cited devices
- K220889: Senhance Surgical System (2022), cited by 1
- K223095: Senhance Surgical System (2023), cited by 1
- K212054: Senhance Surgical System (2021), cited by 1

## Recent decisions
- K254192: Senhance Ultrasonic System (May 12, 2026)
- K233866: Senhance Surgical System (Jul 19, 2024)
- K223095: Senhance Surgical System (Mar 16, 2023)
- K220889: Senhance Surgical System (May 27, 2022)
- K212054: Senhance Surgical System (Aug 30, 2021)
- K211325: Senhance Surgical System (Jul 27, 2021)

Source page: https://510kreport.com/company/asensus-surgical