AUTO-BAND LIGATOR— 510(k) K031236

Name: FDA 510(k) clearance K031236
Creator: U.S. Food and Drug Administration
Published: 2003-11-14

Substantially Equivalent

Scandimed. A.S.

FDA 510(k) clearance K031236 for AUTO-BAND LIGATOR, Substantially Equivalent on 2003-11-14. Applicant: Scandimed. A.S.. Device class: 2.

Clearance details

Applicant: Scandimed. A.S.
Product code: Code MND
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-18
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glostrop, DK

Download summary PDF View on FDA.gov ↗

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K132535 — AUTOBAND LIGATOR2013-08-23
K083556 — MODIFICATION TO AUTO-BAND LIGATOR2009-02-19
K081142 — AUTO-BAND LIGATOR2008-05-16
K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN233212005-10-07
K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U2003-11-06

More clearances from Scandimed. A.S.

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K031238 — VARICES NEEDLE2004-10-04

Adverse events under product code MND

product code MND

Death: 6
Injury: 255
Malfunction: 4,495
Total: 4,756

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.