# K964256: Cygnus Instrument Protectors

- Pathway: 510(k) (Traditional)
- Applicant: Madison Polymeric Engineering
- Decided: May 6, 1997 after 193 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 K771123 (1977). 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)
- K771123: Surgical Instrument Protector, Devon Industries, Inc. (1977) Summary page 1.

## Indications for use
The primary purpose of the device is to protect surgicsl instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits. The linets are first placed into the empty sterilization tray. The instruments are then placed onto the Cygnus liner (or in the pouch) and the trays arc wrapped in CSR wrsp using conventional wrapping methods. Cygnus tray liners are to be used with steam autoclave sterilization only at temperature scttings ranging between - 121°C to 134 °C. The liners may continue to be used during the procedure as a sterile field on which to place instruments. Upon the completion of the procedure the liners are disposed of in gccordance with applicable medical waste regulations.

Source page: https://510kreport.com/device/K964256
Methodology: https://510kreport.com/methodology