# K981322: Cutalon Nylon Polyamide Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Jul 7, 1998 after 88 days
- Product code: GAR (Suture, Nonabsorbable, Synthetic, Polyamide)
- Device class: 2
- Regulation: 21 CFR 878.5020
- 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 K930738 (1994). 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)
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994). Our OCR of the scanned summary read “K930738” beside “510(k)”; FDA’s K930738 is the only number that fits it and was decided on the date printed beside it. Summary page 5.

## Indications for use
“Cutalon” Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K981322
Methodology: https://510kreport.com/methodology