510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994001Substantially Equivalent

Polyglycolic Acid

Trading Consultants and Distributors Intl., Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994001 is the FDA 510(k) clearance record for POLYGLYCOLIC ACID, a class II device, cleared for Trading Consultants and Distributors Intl., Inc. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 6 510(k) clearances for Trading Consultants and Distributors Intl., Inc., from to . As of , FDA records show no recalls naming K994001.

Clearance record

Decision date
Received
(77 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
Trading Consultants and Distributors Intl., Inc. 157 Winddance Dr., Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260