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510(k) K942660

HALL MICROCHOICE ELECTRIC POWERED SYSTEM by Hall Surgical, Division of Zimmer, Inc. — Product Code HWE

K942660 is an FDA 510(k) premarket notification submitted by Hall Surgical, Division of Zimmer, Inc. for the device "HALL MICROCHOICE ELECTRIC POWERED SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 1994. 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. Hall Surgical, Division of Zimmer, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1994
Date Received
June 6, 1994
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 Hall Surgical, Division of Zimmer, Inc.

  • K864734 — HALL ORAL IMPLANT SYSTEM (February 10, 1987)
  • K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST (January 28, 1987)
  • K864163 — HALL DUNBAR DRILL GUIDE SYSTEM (November 20, 1986)
  • K862778 — HALL CANNLULA SYSTEM (September 8, 1986)
  • K862474 — HALL STERNUM SAW (July 17, 1986)
  • K862529 — HALL STERILE BUR (July 15, 1986)
  • K852143 — HALL IRRIGATION SYSTEM (June 26, 1985)

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