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CryoVIVE

by RecensMedical, Inc.

510(k) K203481

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203481 Date13 May 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEH
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CryoVIVE is a cryosurgical unit accessory classified as a medical device under device class 2. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.

CryoVIVE is manufactured by RecensMedical, Inc. and supplied as a non-sterile, reusable device for use in general and plastic surgery settings. It requires storage in accordance with manufacturer guidelines and is not MRI conditional unless explicitly stated.

Other devices from RecensMedical, Inc.

  • TargetCool-e RH-PD06W

    Class II

  • OcuCool ODM-E01

    Not classified

  • OcuCool

    Not classified

  • TargetCool (RM-DT02W)

    Class IIa

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is CryoVIVE used for?

    CryoVIVE is a cryosurgical unit accessory intended for use in general and plastic surgery settings, as indicated by its device classification and advisory committee assignment to those specialties.

  • Is CryoVIVE sterile or non-sterile when supplied?

    CryoVIVE is supplied as a non-sterile device, meaning it must be sterilized by the user before clinical use according to established protocols for reusable surgical accessories.

  • Can CryoVIVE be reused after cleaning and sterilization?

    Yes, CryoVIVE is designed as a reusable device, allowing for multiple uses following appropriate cleaning, disinfection, and sterilization procedures in accordance with the manufacturer’s instructions for reuse.

  • What storage conditions are required for CryoVIVE?

    CryoVIVE must be stored in accordance with the manufacturer’s guidelines to maintain device integrity and performance, though specific temperature or humidity conditions are not detailed in the provided data.

  • Is CryoVIVE safe to use in an MRI environment?

    CryoVIVE is not MRI conditional unless explicitly stated by the manufacturer, so it should not be used in MRI settings without confirmation of MRI compatibility from the labeling or manufacturer.