The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Torrent Irrigation System.
| Device ID | K140405 |
| 510k Number | K140405 |
| Device Name: | TORRENT IRRIGATION SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995184008 | K140405 | 000 |
| 10724995183988 | K140405 | 000 |
| 10724995183971 | K140405 | 000 |
| 10724995183964 | K140405 | 000 |
| 50724995216844 | K140405 | 000 |