# K002546: Civ-Flex Holster Cover, Model Sterile, Latex-Free

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Oct 31, 2000 after 75 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844472 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970513: General Purpose Tranducer Cover, CIVCO Medical Instruments Co., Inc. (1997) Summary page 2.

## Indications for use
A protective cover for a mechanical breast biopsy device reusable holster / cable assembly that helps prevent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for reprocessing of the holster between patient uses; covers are single use, disposable.

Source page: https://510kreport.com/device/K002546
Methodology: https://510kreport.com/methodology