Home / 510(k) Clearances / K063688

510(k) K063688

SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE by The Anspach Effort, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2007
Date Received
December 12, 2006
Clearance Type
Special
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 The Anspach Effort, Inc.

  • K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E (May 19, 2022)
  • K183545 — Anspach Helix Dissection Tools (July 19, 2019)
  • K180063 — OCM-G1 Attachment (March 27, 2018)
  • K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (January 10, 2014)
  • K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (December 31, 2013)
  • K113476 — ANSPACH DISSECTION TOOLS (December 16, 2011)
  • K082637 — CRANIAL PERFORATOR (December 22, 2008)
  • K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, E (April 30, 2008)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K052572 — ANSPACH KNOTLESS ANCHOR (December 5, 2005)

Other clearances for product code HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • 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)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 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)