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510(k) K855150

HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS by Hpk International, Inc. — Product Code LKX

K855150 is an FDA 510(k) premarket notification submitted by Hpk International, Inc. for the device "HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS". The FDA issued a decision of Substantially Equivalent on April 1, 1986. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1986
Date Received
December 26, 1985
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

  • K172358 — Instalief (January 10, 2018)
  • 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)

FDA data resources