LIGHT SABER CORE TISSUE NEEDLE— 510(k) K981796

Substantially Equivalent

Minrad, Inc.

FDA 510(k) clearance K981796 for LIGHT SABER CORE TISSUE NEEDLE, Substantially Equivalent on 1998-08-05. Applicant: Minrad, Inc..

Clearance details

Applicant: Minrad, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1998-05-21
Decision date: 1998-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.