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510(k) K023506

SURGICAL MEDICAL DEVICE CAUTERY by Modern Medical Equipment Mfg., Ltd. — Product Code HQP

K023506 is an FDA 510(k) premarket notification submitted by Modern Medical Equipment Mfg., Ltd. for the device "SURGICAL MEDICAL DEVICE CAUTERY". The FDA issued a decision of Substantially Equivalent on January 13, 2004. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Modern Medical Equipment Mfg., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2004
Date Received
October 18, 2002
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 Modern Medical Equipment Mfg., Ltd.

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES (January 15, 2010)
  • K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT (September 14, 2007)
  • K070877 — ENDOCERVICAL ELECTRODE # 2 (July 27, 2007)
  • K050842 — AGCEL WOUND DRESSING,AGCEL BURN DRESSING (August 2, 2006)
  • K043036 — NON-STICK ELECTRODE (May 6, 2005)
  • K033095 — SMOKE EVACUATION ATTACHEMENT (November 17, 2004)
  • K040238 — SOFTSEAL HSG CATHETER (June 22, 2004)
  • K032327 — MODERN MEDICAL BIPOLAR FORCEPS (June 15, 2004)
  • K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (June 15, 2004)

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)
  • 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)
  • K945762 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (February 7, 1995)

FDA data resources