Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list PROCEPT BioRobotics with 8 510(k) clearances, 2 device recalls and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 9, 2026: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 9, 2026 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)K260723 · PZP | 510(k) clearances |
| Jun 23, 2026 | AQUABEAM Robotic SystemK253211 · PZP | 510(k) clearances |
| Oct 10, 2025 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)K251082 · PZP | 510(k) clearances |
| Oct 10, 2025 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)K251082 · General and Plastic Surgery | AI-enabled devices |
| Sep 30, 2024 | AQUABEAM Robotic System (AB2000)K241952 · PZP | 510(k) clearances |
| Aug 20, 2024 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceK240200 · PZP | 510(k) clearances |
| Aug 20, 2024 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceK240200 · General and Plastic Surgery | AI-enabled devices |
| Aug 30, 2023 | AquaBeam Robotic SystemK231024 · PZP | 510(k) clearances |
| Oct 6, 2021 | AquaBeam Robotic SystemK212835 · PZP | 510(k) clearances |
| Jul 9, 2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.Class II · Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aqua | Device recalls |
| Mar 11, 2021 | AquaBeam Robotic SystemK202961 · PZP | 510(k) clearances |
| Mar 6, 2019 | AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.Class II · Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robo | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
