FDA 510(k)

Meridian Vaginal Positioning System (VPS)

K-Number: K173501 · 2018-02-09

Decision Date2018-02-09

Product CodePWK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Meridian Vaginal Positioning System (VPS) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K173501. The device is classified under product code PWK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meridian Vaginal Positioning System (VPS)?

Meridian Vaginal Positioning System (VPS) is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Coloplast. The 510(k) number is K173501.

When did Meridian Vaginal Positioning System (VPS) receive FDA 510(k) clearance?

Meridian Vaginal Positioning System (VPS) received FDA 510(k) clearance on 2018-02-09, under 510(k) number K173501.

Who is the listed applicant for Meridian Vaginal Positioning System (VPS)?

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

What is the FDA product code for Meridian Vaginal Positioning System (VPS)?

The FDA product code for Meridian Vaginal Positioning System (VPS) is PWK.

Other records listing Coloplast as applicant

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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.