Cleared Traditional

TargetCool

K221234 · Recensmedical, Inc. · General & Plastic Surgery
Jul 2022
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K221234 is an FDA 510(k) clearance for the TargetCool, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Cleared decision on July 22, 2022, 84 days after receiving the submission on April 29, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K221234 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2022
Decision Date July 22, 2022
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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