510(k) K260723
K260723 is an FDA 510(k) premarket notification submitted by Procept Biorobotics for the device "HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)". The FDA issued a decision of Substantially Equivalent on July 9, 2026. The device falls under product code PZP (Fluid Jet Removal System), a Class II device regulated under 21 CFR 876.4350. Procept Biorobotics has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2026
- Date Received
- March 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluid Jet Removal System
- Device Class
- Class II
- Regulation Number
- 876.4350
- Review Panel
- GU
- Submission Type
The system is used for removal of prostate tissue with a fluid jet.