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FDA 510(k)

Berkeley VC-10 Vacuum Curettage System

K-Number: K171440 · 2017-09-29

ApplicantGyrus Acmi
Decision Date2017-09-29
Product CodeHHI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Berkeley VC-10 Vacuum Curettage System is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171440. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Berkeley VC-10 Vacuum Curettage System?

Berkeley VC-10 Vacuum Curettage System is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Gyrus Acmi. The 510(k) number is K171440.

When did Berkeley VC-10 Vacuum Curettage System receive FDA 510(k) clearance?

Berkeley VC-10 Vacuum Curettage System received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171440.

Who is the listed applicant for Berkeley VC-10 Vacuum Curettage System?

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

What is the FDA product code for Berkeley VC-10 Vacuum Curettage System?

The FDA product code for Berkeley VC-10 Vacuum Curettage System is HHI.

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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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