ANGIOMED VAC-U-CUT BIOPSY NEEDLE— 510(k) K862805

Name: FDA 510(k) clearance K862805
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Angiomed U.S., Inc.

FDA 510(k) clearance K862805 for ANGIOMED VAC-U-CUT BIOPSY NEEDLE, Substantially Equivalent on 1986-09-29. Applicant: Angiomed U.S., Inc.. Device class: 1.

Clearance details

Applicant: Angiomed U.S., Inc.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-07-22
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Angiomed U.S., Inc.

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K874771 — ANGIOMED INTRODUCING SETS1988-01-12
K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE1987-12-02
K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT1987-01-30
K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS1986-10-24
K863446 — ANGIOMED HIGH PRESSURE CONNECTORS1986-09-23

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.