510(k) K250695
K250695 is an FDA 510(k) premarket notification submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. for the device "Single-use Ureteral Access Sheath". The FDA issued a decision of Substantially Equivalent on July 8, 2025. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Shenzhen HugeMed Medical Technical Development Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2025
- Date Received
- March 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.