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510(k) K934390

OSCILLATING BONE SAW BLADE, 6200 SERIES by Boehringer Laboratories — Product Code GFA

K934390 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "OSCILLATING BONE SAW BLADE, 6200 SERIES". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1994
Date Received
September 9, 1993
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

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  • K234145 — ViSiGi 3D Gastric Sizing Tube (January 26, 2024)
  • K151990 — Tissue Removal System (September 11, 2015)
  • K150781 — Tissue Removal Pouch (June 19, 2015)
  • K130483 — BOEHRINGER GASTRIC SIZING TUBE (March 28, 2013)
  • K061788 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (July 11, 2006)
  • K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (March 3, 2006)
  • K020538 — BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES (May 15, 2002)
  • K014187 — AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM (February 6, 2002)

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