# K151041: ERBECRYO 2 Cryosurgical Unit with accessories

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: May 4, 2015 after 14 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934261 (1994). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051509: Erbe Erbokryo CA Cryosurgical Unit & Accessories, Erbe USA, Inc. (2005) Summary page 4.

## Most influential descendants
- K190651: 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 (2020), 7 descendants of its own
- K253230: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe (2026), 1 descendant of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K262420: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) (2026), 0 descendants of its own
- K261068: Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) (2026), 0 descendants of its own

## Indications for use
The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion. Clinical Indications for Cryosurgery: Gynecology: Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative), Neoplasia Dermatology: Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus Ophthalmology: Ablatio Retinae, Glaucoma, Lid Tumor ENT: Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma Thoracic Surgery: Post-Operative Urology: Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) Phlebology: Varicose Veins of the Lower Limbs (Cryo Stripping) Proctology: Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor (palliative), Acute Anal Fissures Pulmonology: Tumors, Granulomatous Tissue, Malignant Lesions (palliative) Pneumology: Tracheobronchial Stenoses (Cryo re-canalization)

Source page: https://510kreport.com/device/K151041
Methodology: https://510kreport.com/methodology