The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector.
| Device ID | K143186 |
| 510k Number | K143186 |
| Device Name: | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal ERBE USA, INC. 2225 NORTHWEST PARKWAY Marietta, GA 30067 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-05 |
| Decision Date | 2014-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147013841 | K143186 | 000 |
| 04050147013827 | K143186 | 000 |