MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT— 510(k) K864329

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K864329 for MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT, Substantially Equivalent on 1986-12-03. Applicant: Dlp, Inc..

Clearance details

Applicant: Dlp, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1986-11-04
Decision date: 1986-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, 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.