# K914181: Wang/Mill-Rose Transbronchial Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Mill-Rose Laboratory
- Decided: Dec 10, 1991 after 83 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 9 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963252: TBAN (1996), 19 descendants of its own
- 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

## Recalls of this device
- Nov 20, 2012 · Class II · Z-0502-2013: ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the devi
- Nov 20, 2012 · Class II · Z-0503-2013: ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the devi
- Nov 20, 2012 · Class II · Z-0504-2013: ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the devi
- Nov 20, 2012 · Class II · Z-0505-2013: ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the devi

Source page: https://510kreport.com/device/K914181
Methodology: https://510kreport.com/methodology