FDA applicant
Procept Biorobotics
FDA records 9 decisions for Procept Biorobotics (San Jose, CA) from 2017 to 2026: 8 510(k) clearances and 1 De Novo grant. All are in product code PZP (Fluid Jet Removal System). Its devices cite 9 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Procept Biorobotics, Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Procept Biorobotics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Procept Biorobotics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report