510(k) K240203
K240203 is an FDA 510(k) premarket notification submitted by Dyne Medical Group, Inc. for the device "URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)". The FDA issued a decision of Substantially Equivalent on September 5, 2024. The device falls under product code FGB (Ureteroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Dyne Medical Group, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2024
- Date Received
- January 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ureteroscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To perform various diagnostic and therapeutic procedures within the urinary tract. 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).