# K023025: Self Seal Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Granton Medical, Ltd.
- Decided: Mar 4, 2003 after 174 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052665: Granton Medical 121-135 C Self-Seal Sterilization Pouches (2006), 0 descendants of its own

## Indications for use
The Granton Medical Sterilization Pouches are to be used to enclose another medical device that is to be 121OC gravity steam or ethylene oxide sterilized by a health care provider, following the A N S U A A M I ST-46 OR ST-41 sterilization recommendations.

Source page: https://510kreport.com/device/K023025
Methodology: https://510kreport.com/methodology