BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,— 510(k) K133008

Name: FDA 510(k) clearance K133008
Creator: U.S. Food and Drug Administration
Published: 2013-11-20

Substantially Equivalent

Beacon Endoscopic

FDA 510(k) clearance K133008 for BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,, Substantially Equivalent on 2013-11-20. Applicant: Beacon Endoscopic. Device class: 2.

Clearance details

Applicant: Beacon Endoscopic
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2013-09-25
Decision date: 2013-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburndale, MA, US

Download summary PDF View on FDA.gov ↗

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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.