510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050369Substantially Equivalent

Intuitive Surgical Da Vinci Surgical System, Model Is2000

Intuitive Surgical, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050369 is the FDA 510(k) clearance record for INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000, a class II device, cleared for Intuitive Surgical, Inc. on under FDA product code NAY (System, Surgical, Computer Controlled Instrument). FDA's definition for product code NAY reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 196 510(k) clearances for Intuitive Surgical, Inc., from to . As of , FDA records show 51 recalls naming K050369.

Clearance record

Decision date
Received
(74 days to decision)
Product code
NAY System, Surgical, Computer Controlled Instrument
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Intuitive Surgical, Inc. 950 Kifer Rd., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAY

Trailing 12 months
9 clearances under product code NAY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NAY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20261
April 20260
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260