# K961628: Mini Flex Coil

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Sep 5, 1996 after 132 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- 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 K911806 (1991). 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)
- K924349: General Purpose Flex Coil, Catalog Number M1685GP, General Electric Co. (1992) Summary page 1.
- K911806: Magnetic Resonance Diagnostic Accessory, General Electric Co. (1991) Summary page 1.

## Indications for use
The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.

Source page: https://510kreport.com/device/K961628
Methodology: https://510kreport.com/methodology