CORE BIOPSY NEEDLE, CATALOG CODE #54006— 510(k) K891537

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K891537 for CORE BIOPSY NEEDLE, CATALOG CODE #54006, Substantially Equivalent on 1989-04-18. Applicant: Dlp, Inc..

Clearance details

Applicant: Dlp, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1989-03-17
Decision date: 1989-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.