# K980610: Dexon Rapid (Dexon R)

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: May 18, 1998 after 90 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 1.
- K900198: Dexon II Absorbable Surgical Suture, U.S.P., American Cyanamid Co. (1990) Summary page 1.
- K972566: Dexon Violet, Davis & Geck, Inc. (1997) Summary page 1.

## Indications for use
DEXON® Rapid (DEXON “R”) sutures are indicated for use in the surgical closure of skin and mucosa where only short-term wound support is required and where rapid degradation of the suture material is considered desirable. It is not intended for use in ligation, ophthalmic, cardiovascular or neural tissue.

Source page: https://510kreport.com/device/K980610
Methodology: https://510kreport.com/methodology