SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228— 510(k) K990864

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K990864 for SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228, Substantially Equivalent on 1999-06-11. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MND
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-16
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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.