Ultramatrix EUS Balloon— 510(k) K180731
Substantially EquivalentUnited States Endoscopy Group, Inc. (Us Endoscopy)
FDA 510(k) clearance K180731 for Ultramatrix EUS Balloon, Substantially Equivalent on 2018-04-19. Applicant: United States Endoscopy Group, Inc. (Us Endoscopy). Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc. (Us Endoscopy)
- Product code
- Code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Recent devices under product code ODG
view allAdverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.