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510(k) K895337

ELECTROSURGICAL COAGULATION SUCTION TUBE by New England Surgical Instrument Corp. — Product Code HAM

K895337 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "ELECTROSURGICAL COAGULATION SUCTION TUBE". The FDA issued a decision of Substantially Equivalent on September 15, 1989. The device falls under product code HAM (Apparatus, 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
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by New England Surgical Instrument Corp.

  • K895331 — ELECTROSURGICAL ELECTRODE (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 HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K894663 — BEAMER ONE (September 15, 1989)

FDA data resources