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510(k) K940501

RE-SHARPENABLE SAW BLADES by Adven Medical — Product Code GFA

K940501 is an FDA 510(k) premarket notification submitted by Adven Medical for the device "RE-SHARPENABLE SAW BLADES". The FDA issued a decision of Substantially Equivalent on June 28, 1994. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Adven Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1994
Date Received
February 2, 1994
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 Adven Medical

  • K021528 — REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP (August 21, 2002)
  • K013987 — REPROCESSED DISPOSABLE TROCARS (March 1, 2002)
  • K012675 — REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS (February 12, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 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)
  • 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