PROCEPT BIOROBOTICS CORPORATION

FDA Regulatory Profile

PROCEPT BIOROBOTICS CORPORATION appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2330-2021, Class II) was initiated on July 9, 2021.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

procept biorobotics corporation, procept biorobotics, corporation

Recent Recalls

NumberClassProductDate
Z-2330-2021Class IIAQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.July 9, 2021
Z-1110-2019Class IIAquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic SyMarch 6, 2019