# K053638: Mani Needle & Suture Pack (Silk)

- Pathway: 510(k) (Traditional)
- Applicant: Mani, Inc.
- Decided: May 19, 2006 after 141 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 K760158 (1976). 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)
- K760158: Needles and Sutures, Silk & Nylon, Alcon Laboratories (1976) Summary page 1.

## Indications for use
The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Source page: https://510kreport.com/device/K053638
Methodology: https://510kreport.com/methodology