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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 November 10, 1981. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. American Pharmaceutical Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
September 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by American Pharmaceutical Co., Inc.

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

Other clearances for product code LKX

  • K172358 — Instalief (January 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (April 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (September 30, 2005)
  • K012746 — ICE BATON (November 14, 2001)
  • K981428 — ANU ICE (July 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (August 7, 1995)
  • K921189 — THERMA-H (August 31, 1992)
  • K905276 — THERMA-H (November 7, 1991)

FDA data resources