procept-biorobotics.comAQUABEAM Robotic System (AB2000)
Procept Biorobotics
PROCEPT BioRobotics Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027788423 | 3027788423 | PROCEPT BioRobotics Corporation | 1 | Y | 2026-01-01 | 150 Baytech Drive San Jose CA US 95134 |
| 3012977056 | 3012977056 | PROCEPT BIOROBOTICS CORPORATION | 1 | Y | 2020-04-25 | 900 Island Drive Suite 101 Redwood City CA US 94065 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850055427006 | AquaBeam Handpiece - HP2000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427013 | AquaBeam Scope - SC2000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427020 | AquaBeam Robotic System - AB2000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427037 | AquaBeam Handpiece - HP2000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427044 | Lithotomy Drape - FG351101 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427051 | HYDROS Handpiece - HH1000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427068 | HYDROS Robotic System - HY1000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
| 00850055427075 | HYDROS TRUS Probe - HU1000 | +1(650)232-7222 | customerservice@procept-biorobotics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319440 | 1564938458 | K260723 | HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) | PZP | 2026-07-09 |
| 319440 | 1114221233 | K253211 | AQUABEAM Robotic System | PZP | 2026-06-23 |
| 319440 | 1555933137 | K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) | PZP | 2025-10-10 |
| 319440 | 1701169550 | K241952 | AQUABEAM Robotic System (AB2000) | PZP | 2024-09-30 |
| 319440 | 1606498837 | K240200 | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece | PZP | 2024-08-20 |
| 319440 | 1581509091 | K231024 | AquaBeam Robotic System | PZP | 2023-08-30 |
| 319440 | 1036514370 | K212835 | AquaBeam Robotic System | PZP | 2021-10-06 |
| 319440 | 1446287880 | K202961 | AquaBeam Robotic System | PZP | 2021-03-11 |
| 210054 | 1098565793 | DEN170024 | AQUABEAM System | PZP | 2017-12-21 |
| 319440 | 1098565793 | DEN170024 | AQUABEAM System | PZP | 2017-12-21 |
| 210054 | 1623310986 | ||||
| 210054 | 1913611719 | ||||
| 319440 | 1623310986 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PZP | 10 | 2026-07-09 |
PMN#
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Procept Biorobotics
AquaBeam Robotic System
Procept Biorobotics, Corporation
AquaBeam Robotic System
PROCEPT BioRobotics Corporation
AquaBeam Robotic System
PROCEPT BioRobotics Corporation
GUDID#
Lithotomy Drape - FG351101
2023-12-15
AquaBeam Handpiece - HP2000
2023-08-25
AquaBeam Scope - SC2000
2023-08-25
HYDROS Handpiece - HH1000
2024-09-06
HYDROS Robotic System - HY1000
2024-09-06
HYDROS TRUS Probe - HU1000
2024-09-06
AquaBeam Handpiece - HP2000
2023-12-15
AquaBeam Robotic System - AB2000
2023-08-25
AquaBeam Handpiece - HP2000
2026-04-28
AquaBeam Robotic System - AB2000
2019-03-28
AquaBeam Handpiece - HP2000
2022-05-31
AquaBeam Scope - SC2000
2019-03-28
Essential Drape 1PK - DR2500
2025-03-13
Lithotomy Drape - FG351101
2023-04-05
AquaBeam Handpiece - HP2000
2019-03-28
AquaBeam Robotic System - AB2000C
2021-04-06
AquaBeam System - 210101
2018-01-11
AquaBeam Scope - 210501
2018-01-11
AquaBeam Handpiece - 310301
2018-01-11
Lithotomy Drape - The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
2017-12-06
Essential Drape 1PK - DR2500
2025-03-13
Lithotomy Drape - FG351101
2023-04-05
AquaBeam Scope - SC2000
2019-03-28
AQUABEAM Robotic System - AB2000
2019-01-29