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510(k) K031236

AUTO-BAND LIGATOR by Scandimed. A.S. — Product Code MND

K031236 is an FDA 510(k) premarket notification submitted by Scandimed. A.S. for the device "AUTO-BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on November 14, 2003. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. Scandimed. A.S. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
April 18, 2003
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 Scandimed. A.S.

  • K031238 — VARICES NEEDLE (October 4, 2004)

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)
  • 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