# K014021: Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Specialties Corp
- Decided: Jan 28, 2002 after 53 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 K944110 (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)
- K944110: Vicryl Rapide Suture, ETHICON, Inc. (1995) Summary page 3.

## Indications for use
Sharpoint® Coated FastAbsbrbing‘“ PolyGlycolic Acid Suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa where only short term wound support (7 — 10 days) is required. Coated Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K014021
Methodology: https://510kreport.com/methodology