510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991223Substantially Equivalent

Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut Suture, Plain and Chronic

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

K991223 is the FDA 510(k) clearance record for ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC, a class II device, cleared for Aesculap, Inc. on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K991223.

Clearance record

Decision date
Received
(18 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
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 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