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
K922123Substantially Equivalent

Auto Suture Disposable Endoscopic Specimen Pouch

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922123 is the FDA 510(k) clearance record for AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code GCI (Laryngoscope, Endoscope). 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 K922123.

Clearance record

Decision date
Received
(271 days to decision)
Product code
GCI Laryngoscope, 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 GCI

Trailing 12 months

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

FDA records show no clearances under product code GCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCI, 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