Procept Biorobotics, Corporation
Procept Biorobotics, Corporation holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2023, with 2 FDA device recalls on record.
Top product codes for Procept Biorobotics, Corporation
FDA recalls by Procept Biorobotics, Corporation
- Z-2330-2021 — AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
- Z-1110-2019 — AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Procept Biorobotics, Corporation
Data sourced from openFDA. This site is unofficial and independent of the FDA.