# K964345: Ethicon Absorbable Poly (L-Lactide/Glycolide) Surgical Suture, Undyed

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 16, 1996 after 46 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VICRYL* (Polyglactin Suture): named in the summary without a submission number

## Most influential descendants
- K041806: Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop (2004), 1 descendant of its own
- K040282: Atramat and Sorb-Fast Polyglycolic Acid (2004), 1 descendant of its own
- K063462: Neatstitch Neatclose Suturing Device (2007), 0 descendants of its own
- K042233: Passing Needle with Ethibond, Panacryl or Orthocord Suture (2004), 0 descendants of its own
- K994001: Polyglycolic Acid (2000), 0 descendants of its own

## Recalls of this device
- Feb 16, 2006 · Not classified · Z-0907-06: The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.

## Indications for use
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, or neurological tissue.

Source page: https://510kreport.com/device/K964345
Methodology: https://510kreport.com/methodology