# K993997: Polypropylene

- Pathway: 510(k) (Traditional)
- Applicant: Trading Consultants and Distributors Intl., Inc.
- Decided: Feb 4, 2000 after 72 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945701 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945701: Surgilene (R) Sutures, Davis & Geck, Inc. (1995) Summary page 1.
- (no number) Prolene® Nonabsorbable Polypropylene Surgical Suture (Ethicon, Inc.): named in the summary without a submission number

## Indications for use
POLYPROPYLENE is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K993997
Methodology: https://510kreport.com/methodology