MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
FDA 510(k) clearance K070712 · decided 2007-03-28
Clearance details
- K-number
- K070712
- Device name
- MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
- Applicant
- Surgical Innovations Group Plc
- Decision
- Substantially Equivalent
- Date received
- 2007-03-14
- Decision date
- 2007-03-28
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Leeds, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic proced recall (Z-1853-2022) | Surgical Innovations Ltd | 2022-09-29 |