# K021043: Grams Absorbable Surgical Gut Suture Plain & Chromic

- Pathway: 510(k) (Traditional)
- Applicant: Gramsmed, LLC
- Decided: Jun 21, 2002 after 81 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- 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 K930589 (1993). 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)
- K991223: Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut Suture, Plain and Chronic, Aesculap, Inc. (1999) Summary page 1.
- K994002: Plain/Chromic Catgut, Trading Consultants and Distributors Intl., Inc. (2000) Summary page 1.
- K001299: Plain and Chromic Gut Absorbable Surgical Sutures Usp, Cp Medical (2000) Summary page 1.

## Indications for use
Grams Absorbable Surgical Gut Suture (Plain and Chromic) is 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

Source page: https://510kreport.com/device/K021043
Methodology: https://510kreport.com/methodology