Home / 510(k) Clearances / K013066

510(k) K013066

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE by Olympus America, Inc. — Product Code MND

K013066 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE". The FDA issued a decision of Substantially Equivalent on December 11, 2001. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Olympus America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2001
Date Received
September 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Esophageal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Other clearances by Olympus America, Inc.

  • K111788 — ENDOEYE HD II (January 13, 2012)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K073490 — OLYMPUS IGG REAGENT (February 11, 2008)
  • K073487 — OLYMPUS IGM REAGENT (February 11, 2008)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K061499 — OSFERION (January 26, 2007)
  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
  • K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (October 5, 2006)

Other clearances for product code MND

  • K132535 — AUTOBAND LIGATOR (August 23, 2013)
  • K083556 — MODIFICATION TO AUTO-BAND LIGATOR (February 19, 2009)
  • K081142 — AUTO-BAND LIGATOR (May 16, 2008)
  • K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 (October 7, 2005)
  • K031236 — AUTO-BAND LIGATOR (November 14, 2003)
  • K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (November 6, 2003)
  • K022434 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (August 5, 2002)
  • K001744 — OLYMPUS ENDOSCOPIC LIGATION DEVICE (February 27, 2001)
  • K990864 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 (June 11, 1999)
  • K984255 — OLYMPUS HX-20 SERIES LIGATING DEVICE (January 12, 1999)

FDA data resources