# K142656: Surgical Gut Suture

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Jan 29, 2015 after 133 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885018 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885018: Absorbable Surgical Gut Suture*, United States Surgical, A Division of Tyco Healthc (1989) Summary page 4.

## Recalls of this device
- Mar 1, 2023 · Class II · Z-1388-2023: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, 
- Mar 1, 2023 · Class II · Z-1390-2023: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, 
- Mar 1, 2023 · Class II · Z-1389-2023: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, 

## Indications for use
Plain, Chromic and Mild Chromic gut absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.

Source page: https://510kreport.com/device/K142656
Methodology: https://510kreport.com/methodology