# K180625: Rondek PGA Suture (Beige or Violet)

- Pathway: 510(k) (Traditional)
- Applicant: Rk Manufacturing Corporation
- Decided: May 10, 2018 after 62 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: 3 generations back to K900198 (1990). 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)
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (1999) Summary page 4.

## Indications for use
Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Source page: https://510kreport.com/device/K180625
Methodology: https://510kreport.com/methodology