FDA product code FDX: Endoscopic Cytology Brush
FDX is the FDA product code for endoscopic cytology brush. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 44 510(k) submissions under FDX, 2 in the last five years, from 31 different applicants. The average 510(k) review took 93 days (median 67); 262 days on average over the last three years. FDA has posted 5 recalls for FDX devices, 3 initiated in the last five years.
Definition
To collect cells for cytological evaluation.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Cytology Brush |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FDX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 136 |
| 2018 | 1 | 181 |
| 2019 | 4 | 144 |
| 2022 | 1 | 199 |
| 2025 | 1 | 262 |
Compare with all 510(k) review times · Search every FDX clearance
Top FDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 5 | 2019-11-14 |
| United States Endoscopy Group, Inc. | 4 | 2015-07-30 |
| Cook Incorporated | 2 | 2019-06-26 |
| Medical Device Technologies, Inc. | 2 | 1997-01-08 |
| Annex Medical, Inc. | 2 | 1992-08-25 |
26 more applicants have FDX clearances. See the full list in Caduvo.
Most recent FDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250993 | Olympus Medical Systems Corporation | Single Use Cytology Brush V (BC-V600P-3010) | 2025-12-18 | 262 |
| K220063 | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Single Use Cytology Brush | 2022-07-28 | 199 |
| K192908 | Wilson-Cook Medical, Inc. | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | 2019-11-14 | 30 |
| K191485 | Cook Incorporated | Deflectable Brush Biopsy Set | 2019-06-26 | 22 |
| K182231 | Cook Incorporated | Brush Biopsy Set ; Deflectable Brush Biopsy Set | 2019-05-01 | 257 |
Recalls for FDX devices
5 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-07-29.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code FDX?
FDX is the FDA product code for endoscopic cytology brush. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FDX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDX?
Across 44 cleared submissions the average was 93 days from receipt to decision (median 67).
Which companies have the most FDX clearances?
Wilson-Cook Medical, Inc. (5); United States Endoscopy Group, Inc. (4); Cook Incorporated (2); Medical Device Technologies, Inc. (2); Annex Medical, Inc. (2).
Have FDX devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2022-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FDX
- Run a recall and safety report across every FDX manufacturer
- Watch product code FDX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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