BIPOLAR ENDOSTASIS PROBE, BEST (TM)— 510(k) K915408

Name: FDA 510(k) clearance K915408
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Medical Devices, Inc.

FDA 510(k) clearance K915408 for BIPOLAR ENDOSTASIS PROBE, BEST (TM), Substantially Equivalent on 1992-03-11. Applicant: Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Medical Devices, Inc.
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-02
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.