# K964127: Medi-Vac Flexi-Clear Suction Handle

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Dec 31, 1996 after 77 days
- Product code: GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Argyle® Yankauer Suction Tube: named in the summary without a submission number

## Indications for use
These suction handles are used in conjunction with a vacuum-powered, single patient, body fluid suction apparatus. The handles provide a means to aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum.

Source page: https://510kreport.com/device/K964127
Methodology: https://510kreport.com/methodology