The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Irrigation Pump, Irrigation Biopsy Valve, ,model 00711520, 00711139, 00711140.
| Device ID | K092461 |
| 510k Number | K092461 |
| Device Name: | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Craig Moore |
| Correspondent | Craig Moore UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-11 |
| Decision Date | 2009-11-05 |
| Summary: | summary |