# K971483: Secure-Wrap (TM) Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: American Threshold Industries, Inc.
- Decided: Jun 24, 1997 after 62 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.
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
This device is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.

Source page: https://510kreport.com/device/K971483
Methodology: https://510kreport.com/methodology