The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbeflo 2 Endo Quick Connect Pentax Scope Port Connector.
| Device ID | K191438 |
| 510k Number | K191438 |
| Device Name: | ERBEFLO 2 Endo Quick Connect 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 | 2019-05-30 |
| Decision Date | 2019-06-27 |