The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Oracle Eus Balloon; Oracle Eus Latex Balloon - Olympus Radial; Oracle Eus Latex Balloon - Olympus Linear; Oracle Eus Latex Balloon - Fujinon Radial; Oracle Eus Latex Balloon - Fujinon Linear.
| Device ID | K163492 |
| 510k Number | K163492 |
| Device Name: | Oracle EUS Balloon; Oracle EUS Latex Balloon - Olympus Radial; Oracle EUS Latex Balloon - Olympus Linear; Oracle EUS Latex Balloon - Fujinon Radial; Oracle EUS Latex Balloon - Fujinon Linear |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| 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 | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-13 |
| Decision Date | 2017-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013455 | K163492 | 000 |
| 10816765013448 | K163492 | 000 |
| 10724995184121 | K163492 | 000 |
| 10724995184114 | K163492 | 000 |