# K221340: iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 2, 2023 after 297 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 143 ancestors in all.
No later device cites it as a predicate yet.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 6.
- K163537: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga, Covidien, LLC (2017) Summary page 6.
- K121564: Endoscopic Ultrasound Center EU-Y0006, Olympus Medical Systems Corp. (2012) Summary page 6.
- K212490: AVVIGO Guidance System II, Boston Scientific Corporation (2021) Summary page 6.

## Indications for use
The iNod Ultrasound Guidance Console is intended to be used with iNod Ultrasound Guided Biopsy Needle, to observe and to store real-time ultrasound images of endobronchial lesions, peripheral lung nodules, or lung masses located in airways and tracheobronchial tree. The iNod Ultrasound Guided Biopsy Needle is intended for use through a flexible bronchoscope for intraluminal sonographic imaging in the tracheobronchial tree and retrieval of specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

Source page: https://510kreport.com/device/K221340
Methodology: https://510kreport.com/methodology