# K051509: Erbe Erbokryo CA Cryosurgical Unit & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Jul 27, 2005 after 50 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: 1 generation back to K934261 (1994). 1 ancestor in all.
9 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)
- K934261: Erbokryo CA Cryosurgical System, Erbe Elektromedizin GmbH (1994) Summary page 1.

## Most influential descendants
- K151041: ERBECRYO 2 Cryosurgical Unit with accessories (2015), 8 descendants of its own
- 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

## Indications for use
The ERBE ERBOKRYO® CA 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 (I 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 (Cryorecanalization)

Source page: https://510kreport.com/device/K051509
Methodology: https://510kreport.com/methodology