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PROCEPT BioRobotics Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30277884233027788423PROCEPT BioRobotics Corporation1Y2026-01-01150 Baytech Drive San Jose CA US 95134
30129770563012977056PROCEPT BIOROBOTICS CORPORATION1Y2020-04-25900 Island Drive Suite 101 Redwood City CA US 94065

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850055427006AquaBeam Handpiece - HP2000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427013AquaBeam Scope - SC2000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427020AquaBeam Robotic System - AB2000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427037AquaBeam Handpiece - HP2000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427051HYDROS Handpiece - HH1000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427068HYDROS Robotic System - HY1000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427075HYDROS TRUS Probe - HU1000+1(650)232-7222customerservice@procept-biorobotics.com
00850055427129AquaBeam Handpiece - HP2000+1(650)232-7222customerservice@procept-biorobotics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3194401555933137K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)PZP2025-10-10
3194401701169550K241952AQUABEAM Robotic System (AB2000)PZP2024-09-30
3194401606498837K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpiecePZP2024-08-20
3194401581509091K231024AquaBeam Robotic SystemPZP2023-08-30
3194401036514370K212835AquaBeam Robotic SystemPZP2021-10-06
3194401446287880K202961AquaBeam Robotic SystemPZP2021-03-11
2100541098565793DEN170024AQUABEAM SystemPZP2017-12-21
3194401098565793DEN170024AQUABEAM SystemPZP2017-12-21
2100541623310986
2100541913611719
3194401623310986

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PZP82025-10-10

PMN#

GUDID#

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.

PROCEPT BioRobotics Corporation

2017-12-06