Histofreezer Device
FDA 510(k) K982358 · OraSure Technologies, Inc.
510(k) numberK982358
Submission
- Device name
- Histofreezer Device
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- July 6, 1998
- Decision date
- October 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional | Serpex Medical | 09/02/2026SE |
| K261068 | Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)GEH · Traditional | Serpex Medical | 06/30/2026SE |
| K261806 | ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special | Erbe Elektromedizin GmbH | 06/09/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
More from Recensmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060859 | Compound W Freeze Off Wart Removal SystemGEH · Special | 07/18/2006SE |
| K023487 | Histofreezer Wart Removal System or Other Proprietary NameGEH · Traditional | 03/20/2003SE |
| K013882 | Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IJXM · Traditional | 04/17/2002SE |
| K020371 | Uplink Test SystemDJG · Traditional | 04/03/2002SE |
| K011057 | Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXPJD · Traditional | 06/06/2001SE |
| K002375 | STC Cannabinoids Intercept Micro-Plate Eia, Model 1118ILDJ · Traditional | 01/26/2001SE |
| K001976 | STC Barbiturates Intercept Micro-Plate Eia, Model 1108IDIS · Traditional | 12/06/2000SE |
| K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421DJR · Traditional | 11/29/2000SE |
| K000399 | STC PCP Intercept Micro-Plate Eia, Model 11541LCM · Traditional | 05/15/2000SE |
| K001197 | Cocaine Metabolite Intercept Micro-Plate EiaDIO · Special | 05/11/2000SE |
Questions and answers
When was Histofreezer Device cleared by the FDA?
Histofreezer Device (K982358) received a 510(k) decision of Substantially Equivalent on October 2, 1998, 88 days after the submission was received.
What is the product code of K982358?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.