BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
FDA 510(k) clearance K070420 · decided 2007-03-19
Clearance details
- K-number
- K070420
- Device name
- BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-20
- Decision date
- 2007-03-19
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- ODD
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a T recall (Z-0861-2015) | US Endoscopy Group Inc | 2014-12-23 |