Cleared Special

TargetCool

K220674 · Recensmedical, Inc. · General & Plastic Surgery
Mar 2022
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K220674 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 March 31, 2022, 23 days after receiving the submission on March 8, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K220674 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2022
Decision Date March 31, 2022
Days to Decision 23 days
Submission Type Special
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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