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 a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2021-09-22 under approval 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. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K212667.

When was Single Use Guide Sheath Kit-401, K-402 approved by the FDA?

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

What company makes Single Use Guide Sheath Kit-401, K-402?

Single Use Guide Sheath Kit-401, K-402 is manufactured by Olympus Medical Systems Corp..

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.

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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.