Product Code: LKX
FDA unclassified
Device, Thermal, Hemorrhoids
Unknown
Device, Thermal, Hemorrhoids is a device that applies thermal energy to hemorrhoidal tissue to treat symptomatic hemorrhoids through methods such as infrared coagulation or heat application, causing tissue necrosis and subsequent fibrosis. This device is currently unclassified by the FDA, meaning its formal regulatory classification is pending determination. The product code is LKX; no regulation number or medical specialty has been assigned. The review panel is Gastroenterology/Urology.
510(k)s
18
FEI Numbers
0
Registration Numbers
0
Unique Applicants
17
Years Active
36
Research product code LKX in seconds
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Basic Information
- Product Code
- LKX
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Unclassified Reason
1
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172358 | Instalief | Jan 10, 2018 | Substantially Equivalent | Privi Medical Pte, Ltd. |
| K113660 | COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL | May 03, 2012 | Substantially Equivalent | Cryotherapy Products, Inc. |
| K072414 | CRYOSTAT | Apr 07, 2008 | Substantially Equivalent | Lil Drug Store Products, Inc. |
| K042564 | HEMOR-RITE CRYOTHERAPHY | Sep 30, 2005 | Substantially Equivalent | Fama Holdings International Corp |
| K012746 | ICE BATON | Nov 14, 2001 | Substantially Equivalent | Behive, Ltd. |
| K981428 | ANU ICE | Jul 07, 1998 | Substantially Equivalent | Cryoptherapy Pain Relief Products, Inc. |
| K973590 | HEMORRELIEF DEVICE | Feb 05, 1998 | Substantially Equivalent | A.Stein - Regulatory Affairs Consulting |
| K944874 | ZEROID HEMORRHOIDAL DEVICE | Aug 07, 1995 | Substantially Equivalent | Medical Appliance Research Corp. |
| K921189 | THERMA-H | Aug 31, 1992 | Substantially Equivalent | Zewa AG |
| K905276 | THERMA-H | Nov 07, 1991 | Substantially Equivalent | Kure Swiss Medical AG Corp. |
| K883984 | HEMORX COLD PACK | Dec 22, 1988 | Substantially Equivalent | Bio-Dyne, Inc. |
| K862490 | ANU-RX | Aug 18, 1986 | Substantially Equivalent | J. & Jp., Inc. |
| K855150 | HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS | Apr 01, 1986 | Substantially Equivalent | Hpk International, Inc. |
| K854569 | HEMOR-ICE | Feb 05, 1986 | Substantially Equivalent | Technology 2000 |
| K852679 | MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE | Aug 09, 1985 | Substantially Equivalent | J. & Jp., Inc. |
| K822649 | DEVICE FOR THE TREATMENT OF HEMORRHOIDS | Nov 03, 1982 | Substantially Equivalent | Dunmore Corp. |
| K822217 | THERMOTHERAPY | Sep 24, 1982 | Substantially Equivalent | Luther Medical Products, Inc. |
| K812567 | RELIEF | Nov 10, 1981 | Substantially Equivalent | American Pharmaceutical Co., Inc. |