Data / Medical devices / United States / CS Medical LLC
CS Medical LLC: FDA-registered device maker in Creedmoor, NC, United States, 8 510(k) clearances
CS Medical LLC is registered with the FDA (registration 3005698329) in Creedmoor, NC, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005698329
- Address
- 2179 E Lyon Station Rd, Creedmoor, NC, United States, 27522
- Owner or operator
- CS MEDICAL LLC (9086031)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 19, 2006
- Registered through
- 2026
- Brand names listed
- CS-200895 DSU-H Ultrafilter Installation Kit, CS-200900 DSU-H Ultrafilter Replacement Kit, Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck CI, QwikCheck Chemical Indicator, TD 200 Automated TEE Probe Disinfector and TD-12 High-Level Disinfectant, TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator, TD-100 Automated TEE Probe Disinfector and TD-5 High-Level Disinfectant System, TD-100 Automated TEE Probe Disinfector with TD-5 and TD-8 High-Level Disinfectant System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | PSW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Water Purification, General Medical Use | NHV | 2 | Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2023 | K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
| June 7, 2023 | K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
| April 2, 2020 | K192445 | QwikCheck Chemical Indicators | JOJ | Substantially Equivalent | Serim Research Corporation | accessdata.fda.gov |
| April 1, 2020 | K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
| April 12, 2019 | K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
| November 3, 2016 | K160921 | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
| October 24, 2014 | K141731 | NEPHROS DSU-H, NEPHROS SSU-H | NHV | Substantially Equivalent | Nephros, Inc. | accessdata.fda.gov |
| August 18, 2005 | K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | PSW | Substantially Equivalent | Cs Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Water Purification, General Medical Use
- All makers of Sterilant, Medical Devices
- All makers of High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated November 21, 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.