US ENDOSCOPY CYTOLOGY BRUSH
FDA 510(k) clearance K103437 · decided 2010-12-23
Clearance details
- K-number
- K103437
- Device name
- US ENDOSCOPY CYTOLOGY BRUSH
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-23
- Decision date
- 2010-12-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FDX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisle recall (Z-2396-2012) | US Endoscopy Group Inc | 2012-09-17 |