MANAN MADAYAG PTC NEEDLE— 510(k) K851839

Substantially Equivalent

Manan Manufacturing Co., Inc.

FDA 510(k) clearance K851839 for MANAN MADAYAG PTC NEEDLE, Substantially Equivalent on 1985-06-21. Applicant: Manan Manufacturing Co., Inc..

Clearance details

Applicant: Manan Manufacturing Co., Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1985-04-26
Decision date: 1985-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.