# K102592: Sutrazorb

- Pathway: 510(k) (Abbreviated)
- Applicant: Visionary Medical Supplies, Inc.
- Decided: Feb 3, 2011 after 147 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 K951352 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951352: Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture, Davis & Geck, Inc. (1995) Summary page 1.
- K984374: Surgisorb, Samyang Corp. (1999) Summary page 1.

## Indications for use
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.

Source page: https://510kreport.com/device/K102592
Methodology: https://510kreport.com/methodology