510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073112Substantially Equivalent

Da Vinci Sonicpro Cleaning System, Model 400253

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

K073112 is the FDA 510(k) clearance record for DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253, a class II device, cleared for Intuitive Surgical, Inc. on under FDA product code NVE (Washer, Cleaner, Automated, Endoscope). FDA's definition for product code NVE reads: "This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the...". FDA records list 196 510(k) clearances for Intuitive Surgical, Inc., from to . As of , FDA records show no recalls naming K073112.

Clearance record

Decision date
Received
(270 days to decision)
Product code
NVE Washer, Cleaner, Automated, Endoscope
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 NVE

Trailing 12 months

FDA records hold no clearances under product code NVE in the trailing twelve months.

FDA records show no clearances under product code NVE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NVE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260