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FDA 510(k)

EW-10 AND EW-20

K-Number: K915402 · 1995-06-23

ApplicantOlympus Corp.
Decision Date1995-06-23
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent for Some Indications

Device Summary

EW-10 AND EW-20 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1995-06-23 under 510(k) number K915402. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EW-10 AND EW-20?

EW-10 AND EW-20 is a medical device that received FDA 510(k) clearance on 1995-06-23. The listed applicant is Olympus Corp.. The 510(k) number is K915402.

When did EW-10 AND EW-20 receive FDA 510(k) clearance?

EW-10 AND EW-20 received FDA 510(k) clearance on 1995-06-23, under 510(k) number K915402.

Who is the listed applicant for EW-10 AND EW-20?

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

What is the FDA product code for EW-10 AND EW-20?

The FDA product code for EW-10 AND EW-20 is FEB.

Other records listing Olympus 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.

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Related Devices (Code: FEB)

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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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