# K960004: Cell Recovery System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Mar 20, 1996 after 78 days
- Product code: FDX (Endoscopic Cytology Brush)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Surgitek cytology brush: named in the summary without a submission number
- (no number) Telemed cytology brush: named in the summary without a submission number
- (no number) Microvasive cytology brush: named in the summary without a submission number
- (no number) Wilson-Cook cytology brush: named in the summary without a submission number
- (no number) Wiltek cytology brush: named in the summary without a submission number
- (no number) Hobbs cytology brush: named in the summary without a submission number
- (no number) Mill-Rose cytology brush: named in the summary without a submission number
- (no number) Cook Urological cytology brush: named in the summary without a submission number

## Indications for use
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval cells for cytological evaluation.

Source page: https://510kreport.com/device/K960004
Methodology: https://510kreport.com/methodology