# K062510: Aesculap Sterilcontainer System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap
- Decided: Nov 17, 2006 after 81 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: 3 generations back to K871202 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 1.
- K053389: Aesculap Sterilcontainer System, Aesculap, Inc. (2006) Summary page 1.

## Indications for use
The Aesculap Sterilcontainer System is intended to be used to enclose another medical device(s) that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed device(s) until used. The Aesculap Sterilcontainer System has been validated for use in an ozone sterilization system (TSO3 125L) to include hinged devices and lumened devices as small as 3mm (diameter) and 550 mm (length).

Source page: https://510kreport.com/device/K062510
Methodology: https://510kreport.com/methodology