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510(k) K962544

MICRO DIAMOND-POINT DISSECTION NEEDLES by Dsp Worldwide — Product Code JOS

K962544 is an FDA 510(k) premarket notification submitted by Dsp Worldwide for the device "MICRO DIAMOND-POINT DISSECTION NEEDLES". The FDA issued a decision of Substantially Equivalent on September 20, 1996. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Dsp Worldwide has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1996
Date Received
June 28, 1996
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 by Dsp Worldwide

  • K962371 — DERMTOME BLADE (August 29, 1996)
  • K962365 — XENON LIGHTSOURCE (July 18, 1996)

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)
  • K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, (May 3, 2000)
  • 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)

FDA data resources