# K974299: Panacryl

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Feb 13, 1998 after 88 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.
70 later devices descend from it; 2 cite it directly.
0 of 71 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) ETHICON Absorbable poly (L-lactide/glycolide) Surgical Suture, Undyed: named in the summary without a submission number

## Most influential descendants
- K024117: Insorb Absorbable Staples, Model SP-B20 (2003), 68 descendants of its own
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), 64 descendants of its own
- K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material (2007), 31 descendants of its own
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (2008), 30 descendants of its own
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) (2008), 29 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
Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Sutures, Undyed are indicated for use in general soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissues. The Modified ETHICON Absorbable poly(l-lactide/glycolide Surgical Suture, is particularly useful where extended wound support (up to 6 months) is desirable.

Source page: https://510kreport.com/device/K974299
Methodology: https://510kreport.com/methodology