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510(k) K000333

STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD by Triad Surgical Technologies, Inc. — Product Code JOS

K000333 is an FDA 510(k) premarket notification submitted by Triad Surgical Technologies, Inc. for the device "STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD". The FDA issued a decision of Substantially Equivalent on May 3, 2000. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2000
Date Received
February 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances for product code JOS

  • K161600 — Resection Electrodes (September 6, 2016)
  • K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTI (May 18, 2005)
  • K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE (January 18, 2002)
  • K011515 — MEDLINE GROUNDING PAD (July 13, 2001)
  • K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (May 7, 2001)
  • K993885 — ULTRABLATOR ELECTRODE (February 10, 2000)
  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (August 20, 1999)
  • K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLA (June 24, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (December 19, 1997)
  • K971187 — STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (May 5, 1997)

FDA data resources