510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012201Substantially Equivalent

Premicron Nonabsorbable Pet Surgical Suture

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

K012201 is the FDA 510(k) clearance record for PREMICRON NONABSORBABLE PET SURGICAL SUTURE, a class II device, cleared for Aesculap, Inc. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K012201.

Clearance record

Decision date
Received
(68 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
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 GAT

Trailing 12 months
5 clearances under product code GAT in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260