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510(k) K820157

XOMED THERMAL MYRINGOTOMY SYSTEM by Xomed, Inc. — Product Code HQP

K820157 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XOMED THERMAL MYRINGOTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 1982. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1982
Date Received
January 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code HQP

  • K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN (July 20, 2012)
  • K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTER (September 1, 2009)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K023506 — SURGICAL MEDICAL DEVICE CAUTERY (January 13, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)
  • K990728 — THERMAL CAUTERY DEVICE, FORCEPS (June 3, 1999)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K945761 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP (April 10, 1995)
  • K945763 — LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (February 7, 1995)

FDA data resources