# K970900: Instrument Holder

- Pathway: 510(k) (Traditional)
- Applicant: Contour Fabricators, Inc.
- Decided: May 22, 1997 after 72 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K940891 (1994). 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)
- K940891: Tecnadyne Endoscopic Instrument Holder, Tecnadyne Scientific, Inc. (1994) Summary page 1.

## Indications for use
The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface.

Source page: https://510kreport.com/device/K970900
Methodology: https://510kreport.com/methodology