Home / 510(k) Clearances / K172358

510(k) K172358

Instalief by Privi Medical Pte, Ltd. — Product Code LKX

K172358 is an FDA 510(k) premarket notification submitted by Privi Medical Pte, Ltd. for the device "Instalief". The FDA issued a decision of Substantially Equivalent on January 10, 2018. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2018
Date Received
August 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances for product code LKX

  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (April 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (September 30, 2005)
  • K012746 — ICE BATON (November 14, 2001)
  • K981428 — ANU ICE (July 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (August 7, 1995)
  • K921189 — THERMA-H (August 31, 1992)
  • K905276 — THERMA-H (November 7, 1991)
  • K883984 — HEMORX COLD PACK (December 22, 1988)

FDA data resources