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)

PJUR EROS WATER FORMULATION

K-Number: K010199 · 2001-04-05

ApplicantL.C.C. Pjur Group Germany
Decision Date2001-04-05
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PJUR EROS WATER FORMULATION is the device name listed in this FDA 510(k) record. The listed applicant is L.C.C. Pjur Group Germany. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010199. 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 EROS WATER FORMULATION?

PJUR EROS WATER FORMULATION is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is L.C.C. Pjur Group Germany. The 510(k) number is K010199.

When did PJUR EROS WATER FORMULATION receive FDA 510(k) clearance?

PJUR EROS WATER FORMULATION received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010199.

Who is the listed applicant for PJUR EROS WATER FORMULATION?

The FDA 510(k) record lists L.C.C. Pjur Group Germany as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PJUR EROS WATER FORMULATION?

The FDA product code for PJUR EROS WATER FORMULATION is NUC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.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.

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.

↑