# K062366: Optime, Sinusorb Pga

- Pathway: 510(k) (Traditional)
- Applicant: Peters Surgical
- Decided: Oct 2, 2006 after 49 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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 K022269 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.

## Most influential descendants
- K143584: Pga Resorba, Pga Resoquick, Glycolon (2015), 0 descendants of its own

## Indications for use
The synthetic absorbable surgical sutures OPTIME' and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.

Source page: https://510kreport.com/device/K062366
Methodology: https://510kreport.com/methodology