EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412— 510(k) K040018

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K040018 for EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412, Substantially Equivalent on 2004-01-20. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2004-01-06
Decision date: 2004-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.