Skip to the page
Get started – free

Data / Medical devices / United States / CHS USA Incorporated

CHS USA Incorporated: FDA-registered device maker in Peachtree City, GA, United States, 2 510(k) clearances

CHS USA Incorporated is registered with the FDA (registration 3006450239) in Peachtree City, GA, United States. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 30, 2023. Registered through 2026. 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 CHS USA Incorporated
FDA registration number
3006450239
Address
200 Kelly Drive, Suite A, Peachtree City, GA, United States, 30269
Owner or operator
CHS USA Incorporated (9106219)
Roles
Specification developer
First device listed
December 3, 2024
Registered through
2026
Brand names listed
CHS USA, Chest Drain, Combined Spinal Epidural Anesthesia Kit, Epidural Anesthesia Kit, Minimuffs, Nerve Block, Nerve Tray, PEN NEEDLES 32G x 5/32" (4mm) COMFORT EZ Tri-beveled and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Specification developeraccessdata.fda.gov
Bag, Drainage, With Adhesive, OstomyFON1Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Specification developeraccessdata.fda.gov
Epidural Anesthesia KitOGE2Specification developeraccessdata.fda.gov
General Surgery TrayLRO2Specification developeraccessdata.fda.gov
Holder, Infant PositionFRP1Specification developeraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Specification developeraccessdata.fda.gov
Nerve Block TrayOGJ2Specification developeraccessdata.fda.gov
Protector, Hearing (Circumaural)EWEUSpecification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Specification developeraccessdata.fda.gov
Scale, PatientFRW1Specification developeraccessdata.fda.gov
Spinal Anesthesia KitOFU2Specification developeraccessdata.fda.gov
Spinal Epidural Anesthesia KitOFT2Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Specification developeraccessdata.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
November 30, 2023K230061Insulin SyringeFMFSubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov
September 20, 2023K230043Insulin Pen NeedleFMISubstantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 30, 2023. 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.