# K040282: Atramat and Sorb-Fast Polyglycolic Acid

- Pathway: 510(k) (Traditional)
- Applicant: Internacional Farmaceutica, S.A. DE C.V.
- Decided: Apr 29, 2004 after 83 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 2.
- K964345: Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, Undyed, ETHICON, Inc. (1996) Summary page 2.
- K962480: Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed, ETHICON, Inc. (1996) Summary page 2.
- K944110: Vicryl Rapide Suture, ETHICON, Inc. (1995) Summary page 2.

## Most influential descendants
- K063462: Neatstitch Neatclose Suturing Device (2007), 0 descendants of its own

## Indications for use
Atramat ® Polyglycolic Acid Sutures are 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. sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required, but not for use in ligation, ophthalmic cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K040282
Methodology: https://510kreport.com/methodology