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510(k) K962087

SERVOTRONIC EC100 SYSTEM by Medicon, Inc. — Product Code HWE

K962087 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "SERVOTRONIC EC100 SYSTEM". The FDA issued a decision of Substantially Equivalent on April 23, 1997. 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. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
May 28, 1996
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 Medicon, Inc.

  • K952168 — TITANIUM MANDIBULAR FRACTURE SYSTEM (June 22, 1995)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources