510(k) K232518
K232518 is an FDA 510(k) premarket notification submitted by Endosound, Inc. for the device "EndoSound Vision System; EVS". The FDA issued a decision of Substantially Equivalent on December 27, 2023. The device falls under product code ODG (Endoscopic Ultrasound System, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Endosound, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2023
- Date Received
- August 18, 2023
- Clearance Type
- Traditional
- 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).