# K041096: Wagner Steriset Sterilization Container

- Pathway: 510(k) (Traditional)
- Applicant: Wagner GmbH
- Decided: Jun 3, 2005 after 402 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 K823902 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010825: Medline Steriset Sterilization Container, Medline (2001) Summary page 2.
- K823902: Eagle Steriset, American Sterilizer Co. (1983) Summary page 2.

## Indications for use
The SteriSet Sterilizatoin Conatiner is intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to be used to allow sterilization of the enclosed medical device and also to maintain sterility until used. The SterieSet Containers are designed for use with high-vacuum or pulse-vacuum steam sterilization systems. They are not suitable for gravity, gravity flash, or ethylene oxide (EO) gas cycles due to their "closed design".

Source page: https://510kreport.com/device/K041096
Methodology: https://510kreport.com/methodology