The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. (us Endoscopy) with the FDA for Ultramatrix Eus Balloon.
| Device ID | K180731 |
| 510k Number | K180731 |
| Device Name: | Ultramatrix EUS Balloon |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | United States Endoscopy Group, Inc. (US Endoscopy) 5976 Heisley Road Mentor, OH 44060 |
| Contact | Coletta Cohara |
| Correspondent | Coletta Cohara United States Endoscopy Group, Inc. (US Endoscopy) 5976 Heisley Road Mentor, OH 44060 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-20 |
| Decision Date | 2018-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765014339 | K180731 | 000 |
| 10816765014322 | K180731 | 000 |
| 10724995180772 | K180731 | 000 |
| 10724995180765 | K180731 | 000 |