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510(k) K861876

CRANIO BLADES AND WIRE PASS DRILL by New England Surgical Instrument Corp. — Product Code GFA

K861876 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "CRANIO BLADES AND WIRE PASS DRILL". The FDA issued a decision of Substantially Equivalent on May 30, 1986. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1986
Date Received
May 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Saw, General & Plastic Surgery, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by New England Surgical Instrument Corp.

  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • 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)

Other clearances for product code GFA

  • K971978 — GRAFT HARVESTING SAWBLADES (June 18, 1997)
  • K954483 — STRYKER SAGITTAL SAW ATTACHMENT (January 30, 1996)
  • K955229 — WRIGHT MEDICAL TECHNOLOGY SAWBLADES (January 18, 1996)
  • K953012 — DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (July 12, 1995)
  • K950403 — SURGICAL SAW BLADES (February 21, 1995)
  • K940501 — RE-SHARPENABLE SAW BLADES (June 28, 1994)
  • K933595 — BUR, SURGICAL, GENERAL & PLASTIC SURGERY (March 16, 1994)
  • K935391 — SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PA (February 24, 1994)
  • K934603 — SURGICAL SAW BLADES (February 22, 1994)
  • K931769 — SNAP OSCILLATING SAW (January 27, 1994)

FDA data resources