ENTERYX INJECTION CATHETER
FDA 510(k) clearance K042882 · decided 2004-11-09
Clearance details
- K-number
- K042882
- Device name
- ENTERYX INJECTION CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-10-19
- Decision date
- 2004-11-09
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- FBK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS recall (Z-0040-06) | Boston Scientific Corporation | 2005-10-28 |