# K052665: Granton Medical 121-135 C Self-Seal Sterilization Pouches

- Pathway: 510(k) (Traditional)
- Applicant: Granton Medical, Ltd.
- Decided: Feb 27, 2006 after 153 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
Longest line of descent: 1 generation back to K023025 (2003). 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)
- K023025: Self Seal Sterilization Pouch, Granton Medical, Ltd. (2003) Summary page 1.

## Indications for use
The Granton® Medical 121-135°C Self-Seal Sterilization Pouches (Self Seal Sterilization Pouches) are to be used to enclose another medical device that is to be steam sterilized at 121-135°C by a healthcare provider, following the ANSI/AAMI ST-46 sterilization recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

Source page: https://510kreport.com/device/K052665
Methodology: https://510kreport.com/methodology