# K001299: Plain and Chromic Gut Absorbable Surgical Sutures Usp

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Jun 23, 2000 after 60 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Feb 4, 2019 · Class II · Z-1027-2019: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Source page: https://510kreport.com/device/K001299
Methodology: https://510kreport.com/methodology