# K965162: Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated, Braided-U.S.P.

- Pathway: 510(k) (Traditional)
- Applicant: Lukens Medical Corp.
- Decided: Feb 12, 1997 after 50 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.
17 later devices descend from it; 3 cite it directly.
0 of 18 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) Dexon II polyglycolic acid, synthetic, absorbable surgical sutures USP with polycaprolate coating system: named in the summary without a submission number
- (no number) Dexon I polyglycolic acid surgical sutures: named in the summary without a submission number

## Most influential descendants
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), 15 descendants of its own
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), 14 descendants of its own
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), 10 descendants of its own
- K230311: HyperSuture (2023), 4 descendants of its own
- K191268: Force Fiber Suture (2019), 2 descendants of its own

## Recalls of this device
- Mar 26, 2024 · Class II · Z-1534-2024: Complaints have been received with allegations of Incorrect Needle Curvature.

## Indications for use
The intended use of the device is 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/K965162
Methodology: https://510kreport.com/methodology