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FDA 510(k)

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur

K-Number: K200527 · 2021-02-19

ApplicantPjur Group Luxembourg S.A.
Decision Date2021-02-19
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur is a medical device manufactured by Pjur Group Luxembourg S.A.. It received FDA 510(k) clearance on 2021-02-19 under approval number K200527. 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 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur?

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Pjur Group Luxembourg S.A.. The 510(k) number is K200527.

When was pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur approved by the FDA?

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur received FDA 510(k) clearance on 2021-02-19, under approval number K200527.

What company makes pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur?

pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur is manufactured by Pjur Group Luxembourg S.A..

What is the FDA product code for pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur?

The FDA product code for pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur is NUC.

Related Clinical Trials

NCT02107989 Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database RECRUITING NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07608211 Development of a Sanitizing Tablet for Removable Partial Dentures NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42026173 De novo chemo-optogenetics through the rational design of photoresponsive molecules and selection of their artificial protein binding pairs. Nature chemistry (2026) PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025) PMID: 41100654 Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data. The Indian journal of medical research (2025)

Other Devices by Pjur Group Luxembourg S.A.

K200730pjur WOMAN Nude pjur med SENSITIVE glide K200731pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5

Related Devices (Code: NUC)

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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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