iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)— 510(k) K221340

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K221340 for iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210), Substantially Equivalent on 2023-03-02. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-05-09
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, 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.