Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K944249Substantially Equivalent

Auto Suture* Anti-Fog Device**

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent

K944249 is the FDA 510(k) clearance record for AUTO SUTURE* ANTI-FOG DEVICE**, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB 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 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K944249.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code FEB

Trailing 12 months
1 clearance under product code FEB in the twelve months to November 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FEB, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260