The following data is part of a premarket notification filed by Cipher Surgical Ltd with the FDA for Opclear System.
| Device ID | K171637 |
| 510k Number | K171637 |
| Device Name: | OpClear System |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Cipher Surgical Ltd The Venture Centre, Sir William Lyons Road Coventry, GB Cv4 7ez |
| Contact | Justin Buch |
| Correspondent | David Bentley Cipher Surgical Ltd The Venture Centre, Sir William Lyons Road Coventry, GB Cv4 7ez |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2018-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50603468010014 | K171637 | 000 |
| 50603468006918 | K171637 | 000 |
| 50603468007830 | K171637 | 000 |
| 50603468007762 | K171637 | 000 |
| 50603468007908 | K171637 | 000 |
| 50603468009506 | K171637 | 000 |
| 50603468009674 | K171637 | 000 |
| 50603468009742 | K171637 | 000 |
| 50603468009810 | K171637 | 000 |
| 50603468009988 | K171637 | 000 |
| 50603468006840 | K171637 | 000 |