Cleared Traditional

K203661 - CRYO Arctic, CRYO Penguin (FDA 510(k) Clearance)

K203661 · Cryoscience North America, Inc. · Physical Medicine device
May 2022
Decision
526d
Days
-
Risk

K203661 is an FDA 510(k) clearance for the CRYO Arctic, CRYO Penguin. This device is classified as a Vapocoolant Device.

Submitted by Cryoscience North America, Inc. (Houston, US). The FDA issued a Cleared decision on May 25, 2022, 526 days after receiving the submission on December 15, 2020.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K203661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2020
Decision Date May 25, 2022
Days to Decision 526 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code MLY - Vapocoolant Device
Device Class -