510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771640Substantially Equivalent

Suture Clip Remover

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

K771640 is the FDA 510(k) clearance record for SUTURE CLIP REMOVER, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code GDO (Applier, Surgical, Clip). 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 K771640.

Clearance record

Decision date
Received
(32 days to decision)
Product code
GDO Applier, Surgical, Clip
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
United States Surgical, A Division of Tyco Healthc 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GDO

Trailing 12 months

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

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