NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY— 510(k) K130995

Clearance details

Applicant

Nuance Medical, LLC

Product code

Code GEH

Device class

Class 2

Regulation

21 CFR 878.4350

Advisory panel

General, Plastic Surgery

Date received

2013-04-10

Decision date

2013-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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• K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray2017-10-18
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• K161337 — CryoDose H or Similar2016-07-12

Death

25

Injury

351

Malfunction

901

Total

1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →