The following data is part of a premarket notification filed by Endo Smart Cap Co. with the FDA for Endo Smartcap (100501).
| Device ID | K971125 |
| 510k Number | K971125 |
| Device Name: | ENDO SMARTCAP (100501) |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDO SMART CAP CO. 16800 IMPERIAL VALLEY DR., SUITE 312 Houston, TX 77060 |
| Contact | Don Byrne |
| Correspondent | Don Byrne ENDO SMART CAP CO. 16800 IMPERIAL VALLEY DR., SUITE 312 Houston, TX 77060 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-05-23 |
| Summary: | summary |