# K972719: Claricel Sterilization Pouches and Sterilization Reels

- Pathway: 510(k) (Traditional)
- Applicant: Medicel, S.A. DE C.V.
- Decided: Feb 4, 1999 after 563 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Claricel sterilization pouches and reels are indicated to be used to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.

Source page: https://510kreport.com/device/K972719
Methodology: https://510kreport.com/methodology