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510(k) K981428

ANU ICE by Cryoptherapy Pain Relief Products, Inc. — Product Code LKX

K981428 is an FDA 510(k) premarket notification submitted by Cryoptherapy Pain Relief Products, Inc. for the device "ANU ICE". The FDA issued a decision of Substantially Equivalent on Jul 7, 1998. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 7, 1998
Date Received
Apr 20, 1998
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)
  • 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