510(k) K172358
- Device
- Instalief
- Applicant
- Privi Medical Pte Ltd
- 510(k) number
- K172358
- Product code
- LKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-10
- Date received
- 2017-08-03
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Thermal, Hemorrhoids
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Gastroenterology/Urology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Prusothman M Sinha Raja
- Address
- 79 Ayer Rajah Crescent #05-03 Singapore SG 139955 139955
Source Documents#
Other 510(k) Records For Product Code LKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113660 | COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL | Cryotherapy Products, Inc. | 2012-05-03 |
| K072414 | CRYOSTAT | Lil Drug Store Products, Inc. | 2008-04-07 |
| K042564 | HEMOR-RITE CRYOTHERAPHY | Fama Holdings International Corp | 2005-09-30 |
| K012746 | ICE BATON | Behive, Ltd. | 2001-11-14 |
| K981428 | ANU ICE | Cryoptherapy Pain Relief Products, Inc. | 1998-07-07 |
| K973590 | HEMORRELIEF DEVICE | A.Stein - Regulatory Affairs Consulting | 1998-02-05 |
| K944874 | ZEROID HEMORRHOIDAL DEVICE | Medical Appliance Research Corp. | 1995-08-07 |
| K921189 | THERMA-H | Zewa AG | 1992-08-31 |
| K905276 | THERMA-H | Kure Swiss Medical AG Corp. | 1991-11-07 |
| K883984 | HEMORX COLD PACK | Bio-Dyne, Inc. | 1988-12-22 |
| K862490 | ANU-RX | J. & Jp., Inc. | 1986-08-18 |
| K855150 | HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS | Hpk International, Inc. | 1986-04-01 |
| K854569 | HEMOR-ICE | Technology 2000 | 1986-02-05 |
| K852679 | MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE | J. & Jp., Inc. | 1985-08-09 |
| K822649 | DEVICE FOR THE TREATMENT OF HEMORRHOIDS | Dunmore Corp. | 1982-11-03 |
Legacy Summary#
summary
FDA Review#
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