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

Pleasanton, CA, US

NEOTRACT, INC. appears in FDA device records in Pleasanton, CA. FDA records list 17 510(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
17
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Neotract Inc between 2006 and 2023. The busiest year on record is 2020, with 3. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Neotract Inc, by decision year
YearClearances
20061
20081
20102
20132
20162
20172
20192
20203
20211
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232558UroLift 2 ATC Advanced Tissue Control SystemPEWSubstantially Equivalent
K212396UroLift System Rigid Retrieval Kit Sterilization TrayKCTSubstantially Equivalent
K201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgePEWSubstantially Equivalent
K200441UroLift Advanced Tissue Control (ATC) SystemPEWSubstantially Equivalent
K192781UroLift System Procedure Kit Sterilization TrayKCTSubstantially Equivalent
K193269UroLift System (UL400)PEWSubstantially Equivalent
K190377UroLift System UL400PEWSubstantially Equivalent
K173087UroLift System (UL400 and UL500)PEWSubstantially Equivalent
K172359UroLift System (UL500)PEWSubstantially Equivalent
K162345UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgePEWSubstantially Equivalent
K153584NeoTract UroLift System UL500PEWSubstantially Equivalent
K133281NEOTRACT UROLIFT SYSTEMPEWSubstantially Equivalent
DEN130023UROLIFT SYSTEMPEWUnknown
K102028NEOTRACT ANCHOR SYSTEM MODEL TAS400GATSubstantially Equivalent
K101252NEOTRACT ANCHOR SYSTEM MODEL: REF 11208GATSubstantially Equivalent
K073651NEOTRACT ANCHOR SYSTEMGATSubstantially Equivalent
K061700NEOTRACT ANCHORGAWSubstantially Equivalent

Registered establishments

FDA registered establishments for Neotract Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30151810823005791775NEOTRACT, INC.4155 HOPYARD ROAD, Pleasanton, CA 94588 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-1502-2022UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release ToolThere is the potential that during implant deployment, the device may not properly deliver a implant.Class IIOpen, Classified
Z-0598-2019UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotractUpon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.Class IITerminated

Verification record

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