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510(k) K012746

ICE BATON by Behive, Ltd. — Product Code LKX

K012746 is an FDA 510(k) premarket notification submitted by Behive, Ltd. for the device "ICE BATON". The FDA issued a decision of Substantially Equivalent on Nov 14, 2001. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 14, 2001
Date Received
Aug 16, 2001
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)
  • 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)
  • K883984 — HEMORX COLD PACK (Dec 22, 1988)

FDA data resources