# K971941: Aqua Spray

- Pathway: 510(k) (Traditional)
- Applicant: Boyd Industries, Inc.
- Decided: Aug 14, 1997 after 79 days
- Product code: GEY (Motor, Surgical Instrument, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- 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) Podo Spray: named in the summary without a submission number

## Indications for use
The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.

Source page: https://510kreport.com/device/K971941
Methodology: https://510kreport.com/methodology