PLEURAL BIOPSY PUNCH NEEDLE— 510(k) K881624

Name: FDA 510(k) clearance K881624
Creator: U.S. Food and Drug Administration
Published: 1988-08-11

Substantially Equivalent

E.G. Dick & Assoc.

FDA 510(k) clearance K881624 for PLEURAL BIOPSY PUNCH NEEDLE, Substantially Equivalent on 1988-08-11. Applicant: E.G. Dick & Assoc.. Device class: 1.

Clearance details

Applicant: E.G. Dick & Assoc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-04-12
Decision date: 1988-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, US

Download summary PDF View on FDA.gov ↗

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More clearances from E.G. Dick & Assoc.

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K883876 — WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE1988-10-07
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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.