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510(k) K895331

ELECTROSURGICAL ELECTRODE by New England Surgical Instrument Corp. — Product Code JOS

K895331 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "ELECTROSURGICAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on September 15, 1989. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
August 30, 1989
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 New England Surgical Instrument Corp.

  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K883396 — HANDSWITCHING MONOPOLAR PENCIL (September 13, 1988)
  • K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 (April 19, 1988)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K872271 — VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS (June 26, 1987)
  • K872209 — ARTHROPLASTY MALLET (June 23, 1987)
  • K864770 — SUCTION TUBE (February 24, 1987)
  • K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.) (February 12, 1987)
  • K864771 — CHUCK HANDLE (February 4, 1987)

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