IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
FDA 510(k) clearance K092461 · decided 2009-11-05
Clearance details
- K-number
- K092461
- Device name
- IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-11
- Decision date
- 2009-11-05
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- OCX
- 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 |
|---|---|---|
| Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy va recall (Z-1943-2015) | US Endoscopy Group Inc | 2015-07-01 |