The following data is part of a premarket notification filed by Endomedix with the FDA for Endomedix Y-adapter.
| Device ID | K934170 |
| 510k Number | K934170 |
| Device Name: | ENDOMEDIX Y-ADAPTER |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Randy A Wilson |
| Correspondent | Randy A Wilson ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-27 |
| Decision Date | 1994-01-11 |