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510(k) K050308

THERMAL CAUTERY PROBE by Starion Instruments — Product Code HQR

K050308 is an FDA 510(k) premarket notification submitted by Starion Instruments for the device "THERMAL CAUTERY PROBE". The FDA issued a decision of Substantially Equivalent on February 25, 2005. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Starion Instruments has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2005
Date Received
February 8, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Device Class
Class II
Regulation Number
886.4100
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)
  • 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)
  • K000893 — AC POWERED THERMAL CAUTERY UNIT (June 14, 2000)
  • K001262 — THERMAL CAUTERY FORCEPS (June 14, 2000)
  • K000250 — CAUTERY FORCEPS WITH FOOTSWITCH (March 7, 2000)
  • K000296 — STARION CAUTERY HOOK (March 7, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)

Other clearances for product code HQR

  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K980522 — REFRACTEC MCS-100 (July 22, 1998)
  • K972749 — PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) (March 13, 1998)
  • K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR C (March 4, 1996)
  • K955158 — SURGITRON (February 9, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)

FDA data resources