# K161726: E-Pack Procedure Kit

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Jul 12, 2016 after 20 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: 1 generation back to K970317 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970317: Modified E-Pack Procedure Kit, ETHICON, Inc. (1997) Summary page 5.

## Indications for use
The modified E-PACK™ procedure kits are provided with the same package inserts with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.

Source page: https://510kreport.com/device/K161726
Methodology: https://510kreport.com/methodology