510(k) K191505
K191505 is an FDA 510(k) premarket notification submitted by Nxthera (A Boston Scientific Company) for the device "Rezum System". The FDA issued a decision of Substantially Equivalent on Aug 2, 2019. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Nxthera (A Boston Scientific Company) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 2, 2019
- Date Received
- Jun 6, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type
- 510(k)