Home / 510(k) Clearances / K944874

510(k) K944874

ZEROID HEMORRHOIDAL DEVICE by Medical Appliance Research Corp. — Product Code LKX

K944874 is an FDA 510(k) premarket notification submitted by Medical Appliance Research Corp. for the device "ZEROID HEMORRHOIDAL DEVICE". The FDA issued a decision of Substantially Equivalent on Aug 7, 1995. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 7, 1995
Date Received
Oct 3, 1994
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)
  • K921189 — THERMA-H (Aug 31, 1992)
  • K905276 — THERMA-H (Nov 7, 1991)
  • K883984 — HEMORX COLD PACK (Dec 22, 1988)

FDA data resources