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)

ORTHO CONTROL FEMALE URINARY CONTROL DEVICE

K-Number: K010365 · 2001-04-30

ApplicantPersonal Products Co.
Decision Date2001-04-30
Product CodeMNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORTHO CONTROL FEMALE URINARY CONTROL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Personal Products Co.. It received FDA 510(k) clearance on 2001-04-30 under 510(k) number K010365. The device is classified under product code MNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO CONTROL FEMALE URINARY CONTROL DEVICE?

ORTHO CONTROL FEMALE URINARY CONTROL DEVICE is a medical device that received FDA 510(k) clearance on 2001-04-30. The listed applicant is Personal Products Co.. The 510(k) number is K010365.

When did ORTHO CONTROL FEMALE URINARY CONTROL DEVICE receive FDA 510(k) clearance?

ORTHO CONTROL FEMALE URINARY CONTROL DEVICE received FDA 510(k) clearance on 2001-04-30, under 510(k) number K010365.

Who is the listed applicant for ORTHO CONTROL FEMALE URINARY CONTROL DEVICE?

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

What is the FDA product code for ORTHO CONTROL FEMALE URINARY CONTROL DEVICE?

The FDA product code for ORTHO CONTROL FEMALE URINARY CONTROL DEVICE is MNG.

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

Other records listing Personal Products Co. as applicant

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.

K070545K-Y BRAND WARMING LIQUIDK062796K-Y BRAND INTRIGUEK990536O.B. TAMPONK991118O.B. APPLICATOR TAMPONS, O.B. TAMPONSK974629O.B. APPLICATOR AND NON-APPLICATOR TAMPONSK971589REACH ANTIBACTERIAL TOOTHBRUSH

View all 45 devices →

Related Devices (Code: MNG)

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.

K983164RESTORE (AKA RE/STOR)Nebl, Inc.K974600UROMED PATCHUromed Corp.K974645FEMASSIST FLEXIBLEInsight Medical Corp.K971359RESTORE (A.K.A. CAPSURE)Nebl, Inc.K963858FEMASSIST URINARY DEVICEInsight Medical Corp.K954215MINIGUARDAdvanced Surgical Intervention, 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.

↑