510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911354Substantially Equivalent

Sterile Plain Gut/chromic Gut Absorb Surg Sutures

Internacional Farmaceutica, S.A. de C.V., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911354 is the FDA 510(k) clearance record for STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES, a class II device, cleared for Internacional Farmaceutica, S.A. DE C.V. on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list 11 510(k) clearances for Internacional Farmaceutica, S.A. DE C.V., from to . As of , FDA records show no recalls naming K911354.

Clearance record

Decision date
Received
(213 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Internacional Farmaceutica, S.A. DE C.V. C/O Medical Device Inspection, Great Neck NY
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAL, 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