# K991223: Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut Suture, Plain and Chronic

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 30, 1999 after 18 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Plain and Chromic Absorbable Surgical Suture (Davis & Geck): named in the summary without a submission number
- (no number) Plain and Chromic Absorbable Surgical Suture (Ethicon, Inc.): named in the summary without a submission number
- (no number) SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck): named in the summary without a submission number
- (no number) SURGIGUT® Plain and Chromic Absorbable Surgical Gut Suture (U.S. Surgical Corporation): 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
Absorbable Surgical Gut Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissues.

Source page: https://510kreport.com/device/K991223
Methodology: https://510kreport.com/methodology