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FDA 510(k)

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

K-Number: K212656 · 2021-12-29

ApplicantKarl Storz Endoscopy America
Decision Date2021-12-29
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a medical device manufactured by Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-12-29 under approval number K212656. 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 Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a medical device that received FDA 510(k) clearance on 2021-12-29. It is manufactured by Karl Storz Endoscopy America. The 510(k) number is K212656.

When was Flexible Intubation Video Endoscope – Sterile (FIVE-S) approved by the FDA?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) received FDA 510(k) clearance on 2021-12-29, under approval number K212656.

What company makes Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is manufactured by Karl Storz Endoscopy America.

What is the FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S) is EOQ.

Related Clinical Trials

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Other Devices by Karl Storz Endoscopy America

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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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