LKX — Device, Thermal, Hemorrhoids Class U
FDA product code LKX covers "Device, Thermal, Hemorrhoids", a Class U medical device. Submissions are reviewed by the GU panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKX
- Device Class
- Class U
- Submission Type
- 510(k)
- Review Panel
- GU
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172358 | Privi Medical Pte | Instalief | Jan 10, 2018 |
| K113660 | Cryotherapy Products | COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL | May 3, 2012 |
| K072414 | Lil Drug Store Products | CRYOSTAT | Apr 7, 2008 |
| K042564 | Fama Holdings International | HEMOR-RITE CRYOTHERAPHY | Sep 30, 2005 |
| K012746 | Behive | ICE BATON | Nov 14, 2001 |
| K981428 | Cryoptherapy Pain Relief Products | ANU ICE | Jul 7, 1998 |
| K973590 | A.Stein - Regulatory Affairs Consulting | HEMORRELIEF DEVICE | Feb 5, 1998 |
| K944874 | Medical Appliance Research | ZEROID HEMORRHOIDAL DEVICE | Aug 7, 1995 |
| K921189 | Zewa | THERMA-H | Aug 31, 1992 |
| K905276 | Kure Swiss Medical Ag | THERMA-H | Nov 7, 1991 |
| K883984 | Bio-Dyne | HEMORX COLD PACK | Dec 22, 1988 |
| K862490 | J. And Jp | ANU-RX | Aug 18, 1986 |
| K855150 | Hpk International | HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS | Apr 1, 1986 |
| K854569 | Technology 2000 | HEMOR-ICE | Feb 5, 1986 |
| K852679 | J. And Jp | MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE | Aug 9, 1985 |
| K822649 | Dunmore | DEVICE FOR THE TREATMENT OF HEMORRHOIDS | Nov 3, 1982 |
| K822217 | Luther Medical Products | THERMOTHERAPY | Sep 24, 1982 |
| K812567 | American Pharmaceutical Co | RELIEF | Nov 10, 1981 |