The following data is part of a premarket notification filed by H&o Equipments Nv/sa with the FDA for Cryoprobe.
| Device ID | K024009 | 
| 510k Number | K024009 | 
| Device Name: | CRYOPROBE | 
| Classification | Unit, Cryosurgical, Accessories | 
| Applicant | H&O EQUIPMENTS NV/SA 4655 KIRKWOOD CT. Boulder, CO 80301 | 
| Contact | Lewis Ward | 
| Correspondent | Lewis Ward H&O EQUIPMENTS NV/SA 4655 KIRKWOOD CT. Boulder, CO 80301 | 
| Product Code | GEH | 
| CFR Regulation Number | 878.4350 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2002-12-04 | 
| Decision Date | 2003-03-20 | 
| Summary: | summary | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CRYOPROBE  76455290  3018221 Live/Registered | H&O Equipments N.V./S.A. 2002-10-03 | 
|  CRYOPROBE  75773598  not registered Dead/Abandoned | Endocare, Inc. 1999-08-12 | 
|  CRYOPROBE  75461293  not registered Dead/Abandoned | Pira LUC 1998-04-03 |