510(k) K230475
K230475 is an FDA 510(k) premarket notification submitted by Huger Medical Instrument Co., Ltd. for the device "Medical Video Endoscope System". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code FGB (Ureteroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Huger Medical Instrument Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2023
- Date Received
- February 22, 2023
- 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).