Skip to the page
Get started – free

Data / Medical devices / United States / Centerpoint Systems LLC

Centerpoint Systems LLC: FDA-registered device maker in West Valley City, UT, United States, 14 510(k) clearances

Centerpoint Systems LLC is registered with the FDA (registration 3015970743) in West Valley City, UT, United States. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 29, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Centerpoint Systems LLC
FDA registration number
3015970743
Address
3338 Parkway Blvd., West Valley City, UT, United States, 84119
Owner or operator
CenterPoint Systems LLC (10061099)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer
First device listed
August 19, 2019
Registered through
2027
Brand names listed
AuST Steerable Sheath, CPS Locator 3D Delivery Catheter, CPS Locator 3D Plus Delivery Catheter, Compass Steerable Needle, Compass Steerable Needle with Adapaters SRA-1-01 and SRA-2-01, DF4 Helix Locking Tool, Dragonfly Digital Controller, Dragonfly Instrument Channel Caps and more

Devices it lists

DeviceProduct codeClassRoleSource
Bronchoscope (Flexible Or Rigid)EOQ2Contract manufactureraccessdata.fda.gov
Bronchoscope AccessoryKTI2Contract manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Complaint file establishment, Manufactureraccessdata.fda.gov
Catheter, SteerableDRA2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Complaint file establishment, Manufactureraccessdata.fda.gov
Endoscope Channel AccessoryODC2Complaint file establishment, Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Complaint file establishment, Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Complaint file establishment, Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Complaint file establishment, Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Complaint file establishment, Manufactureraccessdata.fda.gov
Led Light SourceNTN2Complaint file establishment, Manufactureraccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 29, 2026K262240SSPC NXT Delivery CatheterDQYSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
July 29, 2026K261766CPS Locator 3D Plus Delivery CatheterDQYSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
June 5, 2026K261492FieldFlex Steerable SheathDYBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
April 7, 2026K260942AuST Steerable SheathDYBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
August 22, 2025K250147CPS Locator 3D Delivery CatheterDQYSubstantially EquivalentCenterpoint Systemsaccessdata.fda.gov
June 27, 2025K250828CPS Locator 3D Plus Delivery CatheterDQYSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
April 30, 2025K251051AuST Steerable SheathDYBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
December 4, 2024K243180SSPC NXT Delivery CatheterDQYSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
October 4, 2024K242106AuST Steerable SheathDYBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
May 2, 2024K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsFBNSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
May 1, 2024K240829AuST Steerable SheathDYBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
July 31, 2023K223097RenaNav Ureteroscope SystemFGBSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
March 9, 2023K230363CPS Locator 3D Delivery CatheterDQYSubstantially EquivalentCenterPoint Systems, LLCaccessdata.fda.gov
June 28, 2019K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4DQYSubstantially EquivalentCenterpoint Systemsaccessdata.fda.gov

Compare with other makers

Updated July 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.