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510(k) K113660

COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL by Cryotherapy Products, Inc. — Product Code LKX

K113660 is an FDA 510(k) premarket notification submitted by Cryotherapy Products, Inc. for the device "COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL". The FDA issued a decision of Substantially Equivalent on May 3, 2012. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2012
Date Received
December 13, 2011
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 for product code LKX

  • K172358 — Instalief (January 10, 2018)
  • 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)
  • K883984 — HEMORX COLD PACK (December 22, 1988)

FDA data resources