# K994001: Polyglycolic Acid

- Pathway: 510(k) (Traditional)
- Applicant: Trading Consultants and Distributors Intl., Inc.
- Decided: Feb 9, 2000 after 77 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900198 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972566: Dexon Violet, Davis & Geck, Inc. (1997) Summary page 1.
- K964345: Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.

## Indications for use
POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K994001
Methodology: https://510kreport.com/methodology