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FDA 510(k)

VR101 Lubricating Intravaginal Ring

K-Number: K203377 · 2021-05-20

ApplicantJ3 Bioscience, Inc.
Decision Date2021-05-20
Product CodeQPD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VR101 Lubricating Intravaginal Ring is the device name listed in this FDA 510(k) record. The listed applicant is J3 Bioscience, Inc.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203377. The device is classified under product code QPD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VR101 Lubricating Intravaginal Ring?

VR101 Lubricating Intravaginal Ring is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is J3 Bioscience, Inc.. The 510(k) number is K203377.

When did VR101 Lubricating Intravaginal Ring receive FDA 510(k) clearance?

VR101 Lubricating Intravaginal Ring received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203377.

Who is the listed applicant for VR101 Lubricating Intravaginal Ring?

The FDA 510(k) record lists J3 Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VR101 Lubricating Intravaginal Ring?

The FDA product code for VR101 Lubricating Intravaginal Ring is QPD.

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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