510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885018Substantially Equivalent for Some Indications

Absorbable Surgical Gut Suture*

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

K885018 is the FDA 510(k) clearance record for ABSORBABLE SURGICAL GUT SUTURE*, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code GAL (Suture, Absorbable, Natural). 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 K885018.

Clearance record

Decision date
Received
(260 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
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 GAL

Trailing 12 months

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

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