# K050150: Mani Needle & Suture Pack

- Pathway: 510(k) (Traditional)
- Applicant: Mani, Inc.
- Decided: Dec 5, 2005 after 315 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990088 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041894: Orthofiber, Cp Medical (2004) Summary page 1.

## Indications for use
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.

Source page: https://510kreport.com/device/K050150
Methodology: https://510kreport.com/methodology