The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Infinity Ercp Sampling Device.
| Device ID | K151889 |
| 510k Number | K151889 |
| Device Name: | Infinity ERCP Sampling Device |
| Classification | Endoscopic Cytology Brush |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD Mentor, OH 44060 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-10 |
| Decision Date | 2015-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995184046 | K151889 | 000 |
| 10724995184039 | K151889 | 000 |