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510(k) K083556

MODIFICATION TO AUTO-BAND LIGATOR by Scandimed International — Product Code MND

K083556 is an FDA 510(k) premarket notification submitted by Scandimed International for the device "MODIFICATION TO AUTO-BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on February 19, 2009. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Scandimed International has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2009
Date Received
December 2, 2008
Clearance Type
Special
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 Scandimed International

  • K081142 — AUTO-BAND LIGATOR (May 16, 2008)

Other clearances for product code MND

  • K132535 — AUTOBAND LIGATOR (August 23, 2013)
  • 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)
  • K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE (December 11, 2001)
  • 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