510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904578Substantially Equivalent

Modification Auto Suture(r) Endoscopic Clamp

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

K904578 is the FDA 510(k) clearance record for MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code GET (Motor, Surgical Instrument, Pneumatic Powered). 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 K904578.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GET Motor, Surgical Instrument, Pneumatic Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
Third party review
No

Clearances, product code GET

Trailing 12 months

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

FDA records show no clearances under product code GET in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GET, 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 20260
November 20260