Infinity ERCP Sampling Device
FDA 510(k) K151889 · United States Endoscopy Group, Inc.
510(k) numberK151889
Submission
- Device name
- Infinity ERCP Sampling Device
- Applicant
- United States Endoscopy Group, Inc.
Mentor, OH, US - Received
- July 10, 2015
- Decision date
- July 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FDX – Endoscopic Cytology Brush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To collect cells for cytological evaluation.
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|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010)FDX · Traditional | Olympus Medical Systems Corporation | 12/18/2025SE |
| K220063 | Single Use Cytology BrushFDX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 07/28/2022SE |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesFDX · Special | Wilson-Cook Medical, Inc. | 11/14/2019SE |
| K191485 | Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 06/26/2019SE |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy SetFDX · Traditional | Cook Incorporated | 05/01/2019SE |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX · Traditional | Wilson-Cook Medical, Inc. | 02/08/2019SE |
| K172663 | Cytology BrushFDX · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 03/05/2018SE |
| K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushFDX · Traditional | Wilson-Cook Medical, Inc. | 12/29/2017SE |
| K171607 | Bronchi and Gastrointestinal Cytology BrushFDX · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 07/31/2017SE |
| K103437 | US Endoscopy Cytology BrushFDX · Special | United States Endoscopy Group, Inc. | 12/23/2010SE |
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Questions and answers
When was Infinity ERCP Sampling Device cleared by the FDA?
Infinity ERCP Sampling Device (K151889) received a 510(k) decision of Substantially Equivalent on July 30, 2015, 20 days after the submission was received.
What is the product code of K151889?
The FDA product code is FDX – Endoscopic Cytology Brush, a Class II (moderate risk) device regulated under 21 CFR 876.1500.