# K994002: Plain/Chromic Catgut

- Pathway: 510(k) (Traditional)
- Applicant: Trading Consultants and Distributors Intl., Inc.
- Decided: Feb 4, 2000 after 72 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: 1 generation back to K930589 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930589: Plain, Mild Chromic and Chromic Surgical Gut Sutur, Davis & Geck, Inc. (1993) Summary page 1.
- (no number) SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck): named in the summary without a submission number

## Most influential descendants
- K072930: Demetech Absorbable Surgical Suture Plain & Chromic Gut (2008), 0 descendants of its own
- K021043: Grams Absorbable Surgical Gut Suture Plain & Chromic (2002), 0 descendants of its own

## Indications for use
CATGUT 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/K994002
Methodology: https://510kreport.com/methodology