# K963252: TBAN

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 20, 1996 after 32 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: 1 generation back to K914181 (1991). 1 ancestor in all.
19 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914181: Wang/Mill-Rose Transbronchial Aspiration Needle, Mill-Rose Laboratory (1991) Summary page 3.

## Cited in the summary but kept off the family tree
- K840033: Hypodermic Needles & Stylets, Microvasive (1984). Our OCR of the scanned summary read K840033, FDA’s number for Hypodermic Needles & Stylets (Microvasive). Its FDA name has none of the distinctive words the summary uses for the device it names, “Boston Scientific's TBAN”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K040018: Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 (2004), 17 descendants of its own
- K142839: GenCut Core Biopsy System (2015), 15 descendants of its own
- K163537: Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (2017), 14 descendants of its own
- K182188: Ion Endoluminal System ; Flexision Biopsy Needle (2019), 12 descendants of its own
- K202370: Ion Endoluminal System (2020), 5 descendants of its own

## Indications for use
The Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, hilar, and peripheral lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Source page: https://510kreport.com/device/K963252
Methodology: https://510kreport.com/methodology