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510(k) K994019

CAUTERY GRASPER/DISSECTOR by Starion Instruments — Product Code HQP

K994019 is an FDA 510(k) premarket notification submitted by Starion Instruments for the device "CAUTERY GRASPER/DISSECTOR". The FDA issued a decision of Substantially Equivalent on January 20, 2000. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Starion Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2000
Date Received
November 26, 1999
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 Starion Instruments

  • K070871 — STARION UNIVERSAL POWER SUPPLY (April 13, 2007)
  • K062257 — STARION INSTRUMENTS THERMAL LITIGATING SHEARS (October 10, 2006)
  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K043155 — STARION UNIVERSAL POWER SUPPLY (UPS) (December 9, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (June 14, 2000)
  • K001262 — THERMAL CAUTERY FORCEPS (June 14, 2000)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K000250 — CAUTERY FORCEPS WITH FOOTSWITCH (March 7, 2000)
  • K000296 — STARION CAUTERY HOOK (March 7, 2000)

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)
  • 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