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510(k) K854569

HEMOR-ICE by Technology 2000 — Product Code LKX

K854569 is an FDA 510(k) premarket notification submitted by Technology 2000 for the device "HEMOR-ICE". The FDA issued a decision of Substantially Equivalent on Feb 5, 1986. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 5, 1986
Date Received
Nov 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Review Panel
GU
Submission Type
510(k)

Other clearances for product code LKX

  • K172358 — Instalief (Jan 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (Apr 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (Sep 30, 2005)
  • K012746 — ICE BATON (Nov 14, 2001)
  • K981428 — ANU ICE (Jul 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (Feb 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (Aug 7, 1995)
  • K921189 — THERMA-H (Aug 31, 1992)
  • K905276 — THERMA-H (Nov 7, 1991)

FDA data resources