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510(k) K133604

ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS by The Anspach Effort, Inc. — Product Code HBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2014
Date Received
November 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Electric
Device Class
Class II
Regulation Number
882.4360
Review Panel
NE
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)
  • 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)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K052572 — ANSPACH KNOTLESS ANCHOR (December 5, 2005)

Other clearances for product code HBC

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  • K213697 — ORiGO System (October 31, 2022)
  • K220485 — Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, E (May 19, 2022)
  • K193630 — hekaDrill (April 9, 2021)
  • K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools (May 12, 2019)
  • K173066 — OSSEODUO Shaver and Drill System (June 22, 2018)
  • K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw h (May 15, 2017)
  • K163565 — MR8 Drill System (March 28, 2017)
  • K152960 — ELAN 4 Motor System (July 22, 2016)