ENDO-LEADER— 510(k) K954641

Substantially Equivalent

Microsurge, Inc.

FDA 510(k) clearance K954641 for ENDO-LEADER, Substantially Equivalent on 1995-12-28. Applicant: Microsurge, Inc..

Clearance details

Applicant: Microsurge, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1995-10-10
Decision date: 1995-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.