Cleared Traditional

ERBECRYO 2 Cryosurgical Unit (K190651) - FDA 510(k) Clearance

Also marketed or referenced as:
ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch Flexible Cryoprobe ERBECRYO 2 Cart, VIO-Cart, Wire basket Connecting hoses, switching valves, adapter

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190651 · Erbe Elektromedizin GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
300d
Days
Class 2
Risk

K190651 is an FDA 510(k) clearance for the ERBECRYO 2 Cryosurgical Unit. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on January 7, 2020 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Erbe Elektromedizin GmbH devices

Submission Details

510(k) Number K190651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2019
Decision Date January 07, 2020
Days to Decision 300 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 115d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K190651.
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
K201588 · Varian Medical Systems, Inc. · Aug 2020
Frozen N
K193665 · Yozma Bmtech Co., Ltd. · May 2020
Cry-Ac®, Cry-Ac-3®, Cry-Baby
K193619 · Brymill Cryogenic Systems · Mar 2020
IceSense 3, ProSense, MultiSense
K183213 · IceCure Medical , Ltd. · Dec 2019
Claritag
K190747 · Dgi Technologies · Oct 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
K190194 · Pentax Medical, A Division of Pentax of America, Inc. · May 2019