CS Medical LLC
Creedmoor, NC, US
CS MEDICAL LLC appears in FDA device records in Creedmoor, NC. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for CS Medical LLC between 2005 and 2023. The busiest year on record is 2005, with 3. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233049 | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator | PSW | Substantially Equivalent | |
| K230381 | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | PSW | Substantially Equivalent | |
| K192228 | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | PSW | Substantially Equivalent | |
| 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 | |
| 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 | |
| K051305 | CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 | PSW | Substantially Equivalent | |
| K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM | BZR | Substantially Equivalent | |
| K050379 | CS MEDICAL ADULT TTCF CATHETER | BTO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005698329 | 3005698329 | CS MEDICAL LLC | 2179 E Lyon Station Rd, Creedmoor, NC 27522 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
- JOJIndicator, Physical/Chemical Sterilization Process
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- MEDSterilant, Medical Devices
- NHVSystem, Water Purification, General Medical Use
- BTOTube, Tracheostomy (W/Wo Connector)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain