# K130357: Superdimension Triple-Needle Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Nov 6, 2013 after 266 days
- Product code: BTG (Brush, Biopsy, Bronchoscope (Non-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 K834402 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834402: Gastrointestinal Sheath Brush, Hobbs Medical, Inc. (1984) Summary page 3.
- K944650: Wang Bronchial Needle Brush, Mill-Rose Laboratory (1994) Summary page 3.

## Indications for use
To be utilized through a flexible endoscope or the superDimension system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

Source page: https://510kreport.com/device/K130357
Methodology: https://510kreport.com/methodology