# K071111: Non-Absorbable Silk Suture

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jul 17, 2007 after 88 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- 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 K930826 (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)
- K930826: Suture Nonabsorbable - Silk, Surgical Specialties, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K911397: Hypodermic Needles, Single Lumen, Popper & Sons, Inc. (1991). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.

Source page: https://510kreport.com/device/K071111
Methodology: https://510kreport.com/methodology