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510(k) K942108

COHORT BONE BRUSH by Advanced Med/Surg, Inc. — Product Code HWE

K942108 is an FDA 510(k) premarket notification submitted by Advanced Med/Surg, Inc. for the device "COHORT BONE BRUSH". The FDA issued a decision of Substantially Equivalent on October 11, 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. Advanced Med/Surg, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1994
Date Received
May 2, 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 Advanced Med/Surg, Inc.

  • K931538 — AMSET(TM) CANNULATED BONE SCREW (May 4, 1994)
  • K921645 — AMSEN SPINE IMPACTOR INSTRUMENTS (June 3, 1992)
  • K921643 — AMSEN POSTERIOR DISC EVACUATOR (June 3, 1992)
  • K921644 — AMSEN HOCKEY STICK CHISEL (June 3, 1992)
  • K921642 — AMSEN DOUBLE-ENDED FORAMINAL PROBE (June 3, 1992)
  • K905023 — AMSET LOCKING PLATE SYSTEM (January 31, 1992)
  • K911768 — AMSET(TM) BONE SCREW (October 4, 1991)
  • K905014 — AMSET PLD SYSTEM (April 1, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)

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