Home / 510(k) Clearances / K970530

510(k) K970530

ANSPACH LUBRICATING SYSTEM II by The Anspach Effort, Inc. — Product Code GEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
February 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
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)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)
  • K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (August 14, 1996)