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FDA 510(k)

Single Use Guide Sheath Kit-401, K-402

K-Number: K212667 · 2021-09-22

Decision Date2021-09-22
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Single Use Guide Sheath Kit-401, K-402 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K212667. 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-401, K-402?

Single Use Guide Sheath Kit-401, K-402 is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K212667.

When did Single Use Guide Sheath Kit-401, K-402 receive FDA 510(k) clearance?

Single Use Guide Sheath Kit-401, K-402 received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212667.

Who is the listed applicant for Single Use Guide Sheath Kit-401, K-402?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Guide Sheath Kit-401, K-402?

The FDA product code for Single Use Guide Sheath Kit-401, K-402 is EOQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Olympus Medical Systems Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 112 devices →

Related Devices (Code: EOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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