The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Us Endoscopy Distal Attachment Cap.
| Device ID | K140315 |
| 510k Number | K140315 |
| Device Name: | US ENDOSCOPY DISTAL ATTACHMENT CAP |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Sagar D Pimpalwar |
| Correspondent | Sagar D Pimpalwar 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 | 2014-02-10 |
| Decision Date | 2014-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995184787 | K140315 | 000 |
| 10724995184770 | K140315 | 000 |
| 10724995184763 | K140315 | 000 |
| 10724995184756 | K140315 | 000 |
| 10724995184749 | K140315 | 000 |
| 10724995184732 | K140315 | 000 |