HEMOR-RITE CRYOTHERAPHY
FDA 510(k) clearance K042564 · decided 2005-09-30
Clearance details
- K-number
- K042564
- Device name
- HEMOR-RITE CRYOTHERAPHY
- Applicant
- Fama Holdings International Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-09-21
- Decision date
- 2005-09-30
- Days to decision
- 374 days
- Clearance type
- Traditional
- Product code
- LKX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Parkland, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Instalief (K172358) | Privi Medical Pte, Ltd. | 2018-01-10 |
| COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (K113660) | Cryotherapy Products, Inc. | 2012-05-03 |
| CRYOSTAT (K072414) | Lil Drug Store Products, Inc. | 2008-04-07 |
| ICE BATON (K012746) | Behive, Ltd. | 2001-11-14 |
| ANU ICE (K981428) | Cryoptherapy Pain Relief Products, Inc. | 1998-07-07 |
| HEMORRELIEF DEVICE (K973590) | A.Stein - Regulatory Affairs Consulting | 1998-02-05 |
| ZEROID HEMORRHOIDAL DEVICE (K944874) | Medical Appliance Research Corp. | 1995-08-07 |
| THERMA-H (K921189) | Zewa AG | 1992-08-31 |
| THERMA-H (K905276) | Kure Swiss Medical AG Corp. | 1991-11-07 |
| HEMORX COLD PACK (K883984) | Bio-Dyne, Inc. | 1988-12-22 |
| ANU-RX (K862490) | J. & Jp., Inc. | 1986-08-18 |
| HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS (K855150) | Hpk International, Inc. | 1986-04-01 |
Recalls involving this device
No recalls on record reference this clearance.