# K261684: FreezeSpray TA

- Pathway: 510(k) (Traditional)
- Applicant: Cryosurgery, Inc.
- Decided: Sep 5, 2026 after 107 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: 5 generations back to K991514 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102, Nuance Medical, LLC (2016) Summary page 5.
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), Gebauer Company (2017) Summary page 5.

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

Source page: https://510kreport.com/device/K261684
Methodology: https://510kreport.com/methodology