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FDA 510(k)

Symphion Endoscope and Symphion Cervical Sheath

K-Number: K160751 · 2016-06-14

ApplicantBoston Scientific
Decision Date2016-06-14
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Symphion Endoscope and Symphion Cervical Sheath is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2016-06-14 under approval number K160751. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symphion Endoscope and Symphion Cervical Sheath?

Symphion Endoscope and Symphion Cervical Sheath is a medical device that received FDA 510(k) clearance on 2016-06-14. It is manufactured by Boston Scientific. The 510(k) number is K160751.

When was Symphion Endoscope and Symphion Cervical Sheath approved by the FDA?

Symphion Endoscope and Symphion Cervical Sheath received FDA 510(k) clearance on 2016-06-14, under approval number K160751.

What company makes Symphion Endoscope and Symphion Cervical Sheath?

Symphion Endoscope and Symphion Cervical Sheath is manufactured by Boston Scientific.

What is the FDA product code for Symphion Endoscope and Symphion Cervical Sheath?

The FDA product code for Symphion Endoscope and Symphion Cervical Sheath is HIH.

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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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