# K053636: Mani Needle & Suture Pack (Pga  Absorbable)

- Pathway: 510(k) (Traditional)
- Applicant: Mani, Inc.
- Decided: Mar 14, 2006 after 75 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984374 (1999). 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)
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 1.

## Recalls of this device
- Jul 20, 2011 · Not classified · Z-0650-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.
- Jul 20, 2011 · Not classified · Z-0654-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.
- Jul 20, 2011 · Not classified · Z-0649-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.
- Jul 20, 2011 · Not classified · Z-0651-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.
- Jul 20, 2011 · Not classified · Z-0652-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.
- Jul 20, 2011 · Not classified · Z-0653-2012: Surgical sutures may be weak and may not function as intended during surgical procedures.

## Indications for use
The MANI Needle & Suture Pack (PGA Absorbable) 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/K053636
Methodology: https://510kreport.com/methodology