# K030177: Orlon Nonabsorable Surgical Suture Usp

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Orion Pharmaceuticals & Sutures
- Decided: Jul 21, 2003 after 185 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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 K993998 (2000). 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)
- K993998: NYLON, Trading Consultants and Distributors Intl., Inc. (2000) Summary page 2.
- (no number) Surgilon Nonabsorbable Surgical Suture: named in the summary without a submission number

## Indications for use
The ORLON Polyamide Nonabsorbable Needle Suture USP (Polyamide filament) 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/K030177
Methodology: https://510kreport.com/methodology