# K964621: A & E Medical Electrocautery Suction Tube with Finger Tip Activator Button

- Pathway: 510(k) (Traditional)
- Applicant: Alto Development Corp.
- Decided: Dec 20, 1996 after 32 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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) Valleylab Electrovac II Model E2610-6: named in the summary without a submission number
- (no number) A&E Medical Electrocautery Suction Tube Model 050-005: named in the summary without a submission number

## Indications for use
For use with electrosurgical generators that have the accessory finger tip activation feature to control bleeding through the use of suction and cautery.

Source page: https://510kreport.com/device/K964621
Methodology: https://510kreport.com/methodology