# K062100: Arjowrap 47/100 and 47/88

- Pathway: 510(k) (Special)
- Applicant: Arjo Wiggins Medical, Inc.
- Decided: Dec 5, 2006 after 134 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 K931202 (1993). 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)
- K931202: Sterilization Wrap-Sterisheet, Arjo Wiggins Medical, Inc. (1993) Summary page 1.

## Indications for use
ArjoWrap 47/100 and ArjoWrap 47/88 models are single use, non-sterile sterilization wraps intended to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. ArjoWrap 47/100 and ArjoWrap 47/88 maintain the sterility of the enclosed devices until they are used. ArjoWrap 47/100 and ArjoWrap 47/88 are not recommended for any type of irradiation sterilization.

Source page: https://510kreport.com/device/K062100
Methodology: https://510kreport.com/methodology