# K172598: Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE

- Pathway: 510(k) (Traditional)
- Applicant: Itw Contamination Control Electronics
- Decided: Apr 19, 2018 after 233 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991514 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032671: Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07, Gebauer Co. (2004) Summary page 4.

## Indications for use
Coventry ™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Coventry ™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Coventry ™ Medium Stream Spray is also intended for use the management of myofascial pain, restricted motion and muscle tension.

Source page: https://510kreport.com/device/K172598
Methodology: https://510kreport.com/methodology
