510(k) K180731
K180731 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. (Us Endoscopy) for the device "Ultramatrix EUS Balloon". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2018
- Date Received
- March 20, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Ultrasound System, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).