The following data is part of a premarket notification filed by Surgical Innovations Limited with the FDA for Port Access System.
| Device ID | K210495 |
| 510k Number | K210495 |
| Device Name: | Port Access System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Surgical Innovations Limited Clayton Wood House, 6 Clayton Wood Bank Leeds, GB Ls16 6qz |
| Contact | Stephen Seed |
| Correspondent | Stephen Seed Surgical Innovations Limited Clayton Wood House, 6 Clayton Wood Bank Leeds, GB Ls16 6qz |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-22 |
| Decision Date | 2021-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051986013091 | K210495 | 000 |
| 05051986013237 | K210495 | 000 |
| 05051986013220 | K210495 | 000 |
| 05051986013213 | K210495 | 000 |
| 05051986013190 | K210495 | 000 |
| 05051986013176 | K210495 | 000 |
| 05051986013152 | K210495 | 000 |
| 05051986013138 | K210495 | 000 |
| 05051986013114 | K210495 | 000 |
| 05051986012926 | K210495 | 000 |
| 05051986012490 | K210495 | 000 |
| 05051986012247 | K210495 | 000 |
| 05051986013381 | K210495 | 000 |
| 05051986013411 | K210495 | 000 |
| 05051986013244 | K210495 | 000 |
| 05051986013251 | K210495 | 000 |
| 05051986013077 | K210495 | 000 |
| 05051986013374 | K210495 | 000 |
| 05051986013367 | K210495 | 000 |
| 05051986013350 | K210495 | 000 |
| 05051986013343 | K210495 | 000 |
| 05051986013336 | K210495 | 000 |
| 05051986013329 | K210495 | 000 |
| 05051986013312 | K210495 | 000 |
| 05051986013305 | K210495 | 000 |
| 05051986013299 | K210495 | 000 |
| 05051986013282 | K210495 | 000 |
| 05051986013275 | K210495 | 000 |
| 05051986013268 | K210495 | 000 |
| 05051986013398 | K210495 | 000 |