MODIFICATION TO AUTO-BAND LIGATOR— 510(k) K083556

Name: FDA 510(k) clearance K083556
Creator: U.S. Food and Drug Administration
Published: 2009-02-19

Substantially Equivalent

Scandimed International

FDA 510(k) clearance K083556 for MODIFICATION TO AUTO-BAND LIGATOR, Substantially Equivalent on 2009-02-19. Applicant: Scandimed International. Device class: 2.

Clearance details

Applicant: Scandimed International
Product code: Code MND
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-02
Decision date: 2009-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Jamestown, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MND

view all

K132535 — AUTOBAND LIGATOR2013-08-23
K081142 — AUTO-BAND LIGATOR2008-05-16
K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN233212005-10-07
K031236 — AUTO-BAND LIGATOR2003-11-14
K033245 — BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U2003-11-06

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.