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510(k) K822217

THERMOTHERAPY by Luther Medical Products, Inc. — Product Code LKX

K822217 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "THERMOTHERAPY". The FDA issued a decision of Substantially Equivalent on Sep 24, 1982. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device. Luther Medical Products, Inc. has 16 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 24, 1982
Date Received
Jul 26, 1982
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 Luther Medical Products, Inc.

  • K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (Nov 30, 1998)
  • K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) (Mar 24, 1998)
  • K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24… (Feb 10, 1998)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (Dec 15, 1994)
  • K942103 — L-CATH CATHETER SYSTEM - PORT L-CATH (Jul 26, 1994)
  • K930473 — ONECATH L-CATH CATHETER SYSTEM (Apr 7, 1994)
  • K925236 — L CATH(R) CATHETER SYSTEM (Mar 22, 1994)
  • K920755 — L-CATH PEEL AWAY SYSTEM CATHETER (Jun 7, 1993)
  • K925979 — DUAL LUMEN L-CATH CATHETER SYSTEM (May 27, 1993)
  • K924968 — L-CATH PEEL-AWAY CATHETER SYSTEM (May 21, 1993)

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