510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PROCEPT BioRobotics Corporation

San Jose, CA, US

PROCEPT BioRobotics Corporation appears in FDA device records in San Jose, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for PROCEPT BioRobotics Corporation between 2017 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for PROCEPT BioRobotics Corporation, by decision year
YearClearances
20171
20212
20231
20242
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)PZPSubstantially Equivalent
K253211AQUABEAM Robotic SystemPZPSubstantially Equivalent
K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)PZPSubstantially Equivalent
K241952AQUABEAM Robotic System (AB2000)PZPSubstantially Equivalent
K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpiecePZPSubstantially Equivalent
K231024AquaBeam Robotic SystemPZPSubstantially Equivalent
K212835AquaBeam Robotic SystemPZPSubstantially Equivalent
K202961AquaBeam Robotic SystemPZPSubstantially Equivalent
DEN170024AQUABEAM SystemPZPUnknown

Registered establishments

FDA registered establishments for PROCEPT BioRobotics Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30277884233027788423PROCEPT BioRobotics Corporation150 Baytech Drive, San Jose, CA 95134 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2330-2021AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.Class IIOpen, Classified
Z-1110-2019AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain