# Transenterix, Inc.

- Location (FDA's records): Morrisville, NC
- FDA decisions: 15 (2009–2021): 15 510(k) clearances
- Product codes: NAY (9), GCJ (6)
- 510(k) review time since 2016: median 123 days, against 107 for FDA's reviews in the same codes and years (6 of 9 faster)
- Predicates its devices cite: 19 (13 its own); citations of its devices by later devices: 21 (13 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
- Covidien Lp, Formerly Registered AS United States: 2 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)
- Intuitive Surgical, Inc.: 2 (https://510kreport.com/company/intuitive-surgical)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Surgical Innovations Plc: 1 (https://510kreport.com/company/surgical-innovations)

## Firms that cite its devices most
- Intuitive Surgical, Inc.: 3 (https://510kreport.com/company/intuitive-surgical)
- Fortimedix Surgical B.V.: 2 (https://510kreport.com/company/fortimedix-surgical)
- Asensus Surgical, Inc.: 2 (https://510kreport.com/company/asensus-surgical)
- Microline Surgical, Inc.: 1 (https://510kreport.com/company/microline-surgical)

## Its most-cited devices
- K091697: Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (2009), cited by 5
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003 (2009), cited by 3
- K102646: Spider Flex Monopolar Hook (2010), cited by 2
- K202166: Senhance Surgical System (2021), cited by 2
- K171120: Senhance Surgical Robotic System (2017), cited by 2
- K181517: Senhance Surgical System (2018), cited by 2

## Recent decisions
- K202166: Senhance Surgical System (Mar 2, 2021)
- K200049: Senhance Surgical System (Mar 9, 2020)
- K192877: Senhance Surgical System (Nov 22, 2019)
- K191482: Senhance Surgical System (Jul 11, 2019)
- K182421: Senhance Ultrasonic System (Jan 11, 2019)
- K183098: Senhance Surgical System (Dec 6, 2018)
- K181517: Senhance Surgical System (Oct 9, 2018)
- K180163: TransEnterix Senhance Surgical System (May 25, 2018)

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