Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VagiVital Aktivgel

K-Number: K200098 · 2020-11-10

ApplicantPeptonic Medical AB
Decision Date2020-11-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VagiVital Aktivgel is the device name listed in this FDA 510(k) record. The listed applicant is Peptonic Medical AB. It received FDA 510(k) clearance on 2020-11-10 under 510(k) number K200098. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VagiVital Aktivgel?

VagiVital Aktivgel is a medical device that received FDA 510(k) clearance on 2020-11-10. The listed applicant is Peptonic Medical AB. The 510(k) number is K200098.

When did VagiVital Aktivgel receive FDA 510(k) clearance?

VagiVital Aktivgel received FDA 510(k) clearance on 2020-11-10, under 510(k) number K200098.

Who is the listed applicant for VagiVital Aktivgel?

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

What is the FDA product code for VagiVital Aktivgel?

The FDA product code for VagiVital Aktivgel is NUC.

Related Devices (Code: NUC)

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.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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.

↑