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510(k) K812567

RELIEF by American Pharmaceutical Co., Inc. — Product Code LKX

K812567 is an FDA 510(k) premarket notification submitted by American Pharmaceutical Co., Inc. for the device "RELIEF". The FDA issued a decision of Substantially Equivalent on Nov 10, 1981. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. American Pharmaceutical Co., Inc. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 10, 1981
Date Received
Sep 9, 1981
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 by American Pharmaceutical Co., Inc.

  • K945246 — PREVENTOR AND PROTECTOR LATEX CONDOMS (Sep 7, 1995)

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