# K080412: Absorbable Synthetic Suture with Needle Attachment (Pga Braided)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Pudong Jinhuan Medical Products Co., Ltd.
- Decided: Sep 4, 2008 after 202 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: 1 generation back to K951352 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 1.
- K951352: Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture, Davis & Geck, Inc. (1995) Summary page 1.

## Indications for use
Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is indicated for use in general soft tissue approximation including ophthalmic surgery. Absorbable Synthetic Suture with Needle Attachment (PGA BRAIDED) is not indicated for cardiovascular and neurological tissue approximation.

Source page: https://510kreport.com/device/K080412
Methodology: https://510kreport.com/methodology