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FDA 510(k)

ShenDa Sinuscope

K-Number: K161298 · 2017-08-25

ApplicantShenyang Shenda Endoscope Co., Ltd.
Decision Date2017-08-25
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ShenDa Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is Shenyang Shenda Endoscope Co., Ltd.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K161298. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShenDa Sinuscope?

ShenDa Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Shenyang Shenda Endoscope Co., Ltd.. The 510(k) number is K161298.

When did ShenDa Sinuscope receive FDA 510(k) clearance?

ShenDa Sinuscope received FDA 510(k) clearance on 2017-08-25, under 510(k) number K161298.

Who is the listed applicant for ShenDa Sinuscope?

The FDA 510(k) record lists Shenyang Shenda Endoscope Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ShenDa Sinuscope?

The FDA product code for ShenDa Sinuscope is EOB.

Related Devices (Code: EOB)

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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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.

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