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510(k) K962313

MODIFIED LEVEEN NEEDLE ELECTRODE by Radiotherapeutics Corp. — Product Code JOS

K962313 is an FDA 510(k) premarket notification submitted by Radiotherapeutics Corp. for the device "MODIFIED LEVEEN NEEDLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 11, 1996. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Radiotherapeutics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1996
Date Received
June 17, 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 Radiotherapeutics Corp.

  • K011220 — LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE (July 1, 2002)
  • K012315 — LEVEEN ELECTRODE (October 11, 2001)
  • K000241 — RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR (April 14, 2000)
  • K982556 — LEVEEN NEEDLE ELECTRODE (April 6, 2000)
  • K000032 — LEVEEN NEEDLE ELECTRODE (March 30, 2000)
  • K982854 — MR COMPATIBLE LEVEEN NEEDLE ELECTRODE (November 10, 1998)
  • K981672 — RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR (July 17, 1998)
  • K972441 — RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 (September 4, 1997)
  • K962386 — SENSOR SHEATH TS1 (August 20, 1996)
  • K955144 — RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 (April 7, 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