510(k) clearance
Rezum System
- 510(k) number
- K262460
- Applicant
- Boston Scientific
- Decision date
- Sep 3, 2026
- Date received
- Jul 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KNS
- Device type
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device class
- Class II
- Regulation
- 21 CFR 876.4300
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Marlborough, MA, US