# K970317: Modified E-Pack Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Apr 25, 1997 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) E-PACK Procedural Kit: named in the summary without a submission number

## Most influential descendants
- K161726: E-Pack Procedure Kit (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K970317
Methodology: https://510kreport.com/methodology