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Endoscopic Cytology Brush
FDA product code FDX · Class 2 · Gastroenterology, Urology
130
Registered devices
695
Adverse events
5
Recalls
44
510(k) clearances
Devices with this code
Fusion — COOK INCORPORATEDForeign Body Retrieval Basket — Avanos Medical, Inc.Cook — COOK INCORPORATEDSingle Use Cytology Brush — Zhejiang Chuangxiang Medical Technology Co., LTD.CytoMax II — COOK INCORPORATEDFusion — COOK INCORPORATEDHobbs Medical Cytology Brush — HOBBS MEDICAL, INC.CONMED — Conmed CorporationCONMED — Conmed CorporationHobbs Medical Cytology Brush — HOBBS MEDICAL, INC.Infinity — US EndoscopySingle Use Cytology Brush — Zhejiang Chuangxiang Medical Technology Co., LTD.CONMED — Conmed CorporationInfinity — US EndoscopyDISPOSABLE CYTOLOGY BRUSH — OLYMPUS MEDICAL SYSTEMS CORP.Cytology Brush — Micro-Tech (Nanjing) Co., Ltd.Cook — COOK INCORPORATEDEndoTBrush Cytology Brush — ENDO-THERAPEUTICS, INC.Single Use Cytology Brush — Zhejiang Chuangxiang Medical Technology Co., LTD.Disposable Gastrointestinal Cytology Brush — Telemed SystemsCONMED — Conmed CorporationCytology Brush — Micro-Tech (Nanjing) Co., Ltd.Cytology Brush — Avanos Medical, Inc.superDimension — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9 |
| 2021-12-28 | Hobbs Medical, Inc. | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not |
| 2018-05-01 | Hobbs Medical, Inc. | Device was marketed for uses outside the 510(k) clearance. |
| 2006-10-12 | Ekos Corp | Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard. |
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