510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011375Substantially Equivalent

Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture

Aesculap Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011375 is the FDA 510(k) clearance record for AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE, a class II device, cleared for Aesculap, Inc. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K011375.

Clearance record

Decision date
Received
(56 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aesculap, Inc. 13221 Maricotte Pl., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code GAM

Trailing 12 months
6 clearances under product code GAM in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260