Port Access System
FDA 510(k) clearance K210495 · decided 2021-06-18
Clearance details
- K-number
- K210495
- Device name
- Port Access System
- Applicant
- Surgical Innovations Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-02-22
- Decision date
- 2021-06-18
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Leeds, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR recall (Z-1601-2023) | Surgical Innovations Ltd | 2023-05-17 |
| YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR recall (Z-1602-2023) | Surgical Innovations Ltd | 2023-05-17 |