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510(k) K953012

DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS by Boston Surgical Products, Inc. — Product Code GFA

K953012 is an FDA 510(k) premarket notification submitted by Boston Surgical Products, Inc. for the device "DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Boston Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
June 28, 1995
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 Boston Surgical Products, Inc.

  • K972311 — MODEL 20 BIPOLAR COAGULATOR (September 18, 1997)
  • K972350 — MODEL 50 BIPOLAR COAGULATOR (August 21, 1997)
  • K944947 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS (July 28, 1995)
  • K950375 — DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR (June 14, 1995)
  • K951912 — DISOPOSABLE & RESUABLE MONPOLAR CORD (May 12, 1995)
  • K951269 — DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL (April 24, 1995)
  • K950877 — REUSABLE MONOPOLAR FORCEPS (March 9, 1995)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)
  • K945893 — DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE (December 13, 1994)
  • K945717 — ELECTROSURGICAL ENDOSCOPIC CORD (December 8, 1994)

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)
  • 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)
  • K934390 — OSCILLATING BONE SAW BLADE, 6200 SERIES (January 26, 1994)

FDA data resources