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FDA 510(k)

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

K-Number: K160921 · 2016-11-03

ApplicantCs Medical, LLC
Decision Date2016-11-03
Product CodePSW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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 is a medical device manufactured by Cs Medical, LLC. It received FDA 510(k) clearance on 2016-11-03 under approval number K160921. The device is classified under product code PSW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Cs Medical, LLC. The 510(k) number is K160921.

When was 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 approved by the FDA?

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 received FDA 510(k) clearance on 2016-11-03, under approval number K160921.

What company makes 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?

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 is manufactured by Cs Medical, LLC.

What is the FDA product code for 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?

The FDA product code for 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 is PSW.

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Related PubMed Literature

PMID: 41815749 The history of state preemption and medical device regulation: lessons for artificial intelligence oversight. Health affairs scholar (2026) PMID: 41453025 Characterization and Time-delay in Issuing High-risk Recalls of Orthopaedic Devices From 2002 to 2023. The Journal of the American Academy of Orthopaedic Surgeons (2025) PMID: 41428154 Level of Evidence and Strength of Recommendations in US Medical Society Clinical Practice Guidelines, 2019-2023: A Cross-Sectional Analysis. Journal of general internal medicine (2025) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Cs Medical, LLC

K182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator

Related Devices (Code: PSW)

K182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level DisinfectantsCs Medical, LLC K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLC K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLC K230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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