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FDA 510(k)

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

K-Number: K192164 · 2020-03-06

ApplicantOlympus Medical Systems Corp.
Decision Date2020-03-06
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-03-06 under approval number K192164. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR?

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K192164.

When was Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR approved by the FDA?

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR received FDA 510(k) clearance on 2020-03-06, under approval number K192164.

What company makes Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR?

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR?

The FDA product code for Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR is EOQ.

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41929241 A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study. Medical devices (Auckland, N.Z.) (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

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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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