# K143584: Pga Resorba, Pga Resoquick, Glycolon

- Pathway: 510(k) (Traditional)
- Applicant: Resorba Medical GmbH
- Decided: Nov 2, 2015 after 319 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: 2 generations back to K022269 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 6.
- K011372: Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2001) Summary page 6.
- K062366: Optime, Sinusorb Pga, Peters Surgical (2006) Summary page 6.
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified), ETHICON, Inc. (1996) Summary page 6.

## Indications for use
GLYCOLON® is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue. PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K143584
Methodology: https://510kreport.com/methodology