The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Clearpath 24.
| Device ID | K112318 |
| 510k Number | K112318 |
| Device Name: | CLEARPATH 24 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | PROMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PROMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2012-06-29 |
| Summary: | summary |