BIOPSY NEEDLE GUIDE KIT, STERILE— 510(k) K871467

Name: FDA 510(k) clearance K871467
Creator: U.S. Food and Drug Administration
Published: 1987-08-21

Substantially Equivalent

Amedic USA

FDA 510(k) clearance K871467 for BIOPSY NEEDLE GUIDE KIT, STERILE, Substantially Equivalent on 1987-08-21. Applicant: Amedic USA. Device class: 2.

Clearance details

Applicant: Amedic USA
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1987-04-14
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amedic USA

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K897120 — EQUIP COVERS, STERILE1990-01-04
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K892069 — EXTENDED COVERS, STERILE1989-08-08
K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE1989-08-08
K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE1989-08-04

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.