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510(k) K880150

PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM by Dyonics, Inc. — Product Code HWE

K880150 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1988. 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. Dyonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1988
Date Received
January 13, 1988
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 Dyonics, Inc.

  • K900070 — MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM (February 16, 1990)
  • K896416 — DYONICS SHOULDER PORTAL SYSTEM (January 2, 1990)
  • K893136 — SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY (December 14, 1989)
  • K890665 — MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES (November 3, 1989)
  • K894728 — DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE (August 18, 1989)
  • K892062 — PS3500 ARTHROSCOPIC SURGICAL SYSTEM (June 23, 1989)
  • K884839 — MODIFIED SAW BLADES TO THE SAGITAL SAW (December 7, 1988)
  • K881876 — DYNAMIC CRUCIATE TESTER (November 17, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K870212 — ARTHROSCOPIC SHOULDER HOLDER (February 20, 1987)

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