# Intuitive Surgical, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 198 (1997–2026): 198 510(k) clearances
- Names in FDA's records: Intuitive Surgical, Inc. (181); Intuitive Surgical (17)
- Product codes: NAY (147), GCJ (18), EOQ (11), KCT (7), GEI (6), QIH (2), LLZ (1), OWN (1), LKF (1), HET (1), NVE (1), GAG (1)
- 510(k) review time since 2016: median 95 days, against 117 for FDA's reviews in the same codes and years (71 of 125 faster)
- Predicates its devices cite: 600 (551 its own); citations of its devices by later devices: 593 (551 its own)
- Recalls linked to its devices: 261 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 5 (https://510kreport.com/company/ethicon-endo-surgery)
- Transenterix, Inc.: 3 (https://510kreport.com/company/transenterix)
- Cryocath Technologies, Inc.: 3 (https://510kreport.com/company/cryocath-technologies)
- United States Surgical, A Division of Tyco Healthc: 2 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Covidien Lp, Formerly Registered AS United States: 2 (https://510kreport.com/company/covidien-lp-formerly-registered-as-united-states)
- Olsen Medical: 2 (https://510kreport.com/company/olsen-medical)
- Surgrx, Inc.: 2 (https://510kreport.com/company/surgrx)
- Gyrus Medical, Inc.: 1 (https://510kreport.com/company/gyrus-medical)

## Firms that cite its devices most
- Rebotix: 15 (https://510kreport.com/company/rebotix)
- Iconocare Health: 7 (https://510kreport.com/company/iconocare-health)
- Asensus Surgical, Inc.: 2 (https://510kreport.com/company/asensus-surgical)
- Transenterix, Inc.: 2 (https://510kreport.com/company/transenterix)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Stryker Endoscopy: 1 (https://510kreport.com/company/stryker-endoscopy)
- Novadaq Technologies, Inc.: 1 (https://510kreport.com/company/novadaq-technologies)
- Zhuhai Dipu Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-dipu-medical-technology)

## Its most-cited devices
- K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories (2014), cited by 32
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 (2009), cited by 29
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System (2000), cited by 21
- K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 (2009), cited by 20
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000 (2005), cited by 20
- K171294: da Vinci X Surgical System (2017), cited by 16

## Recent decisions
- K262455: da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (Oct 14, 2026)
- K261823: da Vinci Surgical System, Model IS5000 (Sep 8, 2026)
- K253702: Intuitive Endoluminal Gastrointestinal System (IG1000) (Aug 7, 2026)
- K261824: da Vinci Surgical System, Model IS5000 (Jul 31, 2026)
- K261249: Universal Seal (5-12 mm) (Jul 14, 2026)
- K260695: da Vinci Firefly Imaging System (May 22, 2026)
- K253986: da Vinci Force Feedback Instruments (Mar 11, 2026)
- K253978: Universal Seal (5-12 mm) (Feb 24, 2026)

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