Atlas FDA

ERBECRYO 2 Cryosurgical Unit; 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

FDA 510(k) clearance K190651 · decided 2020-01-07

Clearance details

K-number
K190651
Device name
ERBECRYO 2 Cryosurgical Unit; 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
Applicant
Erbe Elektromedizin GmbH
Decision
Substantially Equivalent
Date received
2019-03-13
Decision date
2020-01-07
Days to decision
300 days
Clearance type
Traditional
Product code
GEH
Device class
2
Regulation number
878.4350
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Tuebingen, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Erbe Elektromedizin GmbH

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (K261068)Serpex Medical2026-06-30
ERBECRYO 2 Cryosurgical Unit and Accessories (K261806)Erbe Elektromedizin GmbH2026-06-09
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (K253230)Erbe Elektromedizin GmbH2026-04-22
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (K252198)Medical Brands Laboratories B.V.2026-04-02
XSense Cryoablation System with CryoProbes (K260377)IceCure Medical , Ltd.2026-02-24
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928)Medinice S.A.2026-02-13
Dr. Yglo Skin Tag Remover (K251524)Theotclab Healthcare B.V.2026-01-12
Focused Cryotherapy System (K250742)Focused Cryo, Inc.2025-12-09
CryoFreeze Wart and Skin Tag Remover (K253000)Cryosurgery, Inc.2025-10-16
TargetCoolâ„¢ (RM-DT02W) (K253114)Recensmedical, Inc.2025-10-16
TargetCool-e (K253348)Recensmedical, Inc.2025-10-15
Verruca-Freeze H Plus (K252903)Cryosurgery, Inc.2025-10-10

Recalls involving this device

RecordFirmDate
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 recall (Z-2938-2026)Erbe USA Inc2026-08-12
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STER recall (Z-1566-2026)Erbe USA Inc2026-03-20
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use recall (Z-1567-2026)Erbe USA Inc2026-03-20
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use recall (Z-1568-2026)Erbe USA Inc2026-03-20