# K834402: Gastrointestinal Sheath Brush

- Pathway: 510(k) (Traditional)
- Applicant: Hobbs Medical, Inc.
- Decided: Feb 4, 1984 after 52 days
- Product code: FDX (Endoscopic Cytology Brush)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K130357: Superdimension Triple-Needle Cytology Brush (2013), 0 descendants of its own

## Recalls of this device
- May 1, 2018 · Class II · Z-2052-2018: Device was marketed for uses outside the 510(k) clearance.

Source page: https://510kreport.com/device/K834402
Methodology: https://510kreport.com/methodology