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510(k) K012694

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS by Adven Medical — Product Code HWE

K012694 is an FDA 510(k) premarket notification submitted by Adven Medical for the device "REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS". The FDA issued a decision of Substantially Equivalent on February 4, 2002. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), 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
February 4, 2002
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
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)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K940501 — RE-SHARPENABLE SAW BLADES (June 28, 1994)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)
  • K973560 — BONE GRAFT HARVESTER (November 12, 1997)

FDA data resources