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FDA PMA

Single-use internal condom

PMA Number: P080002 · 2017-06-23

ApplicantClear Future, Inc.
Decision Date2017-06-23
PMA NumberP080002
Product CodeMBU
Device ClassClass 2
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOB

Device Summary

Single-use internal condom is the device name listed in this FDA 510(k) record. The listed applicant is Clear Future, Inc.. It received FDA 510(k) clearance on 2017-06-23. The device is classified under product code MBU. It was reviewed by the OB advisory panel.

Frequently Asked Questions

What is the Single-use internal condom?

Single-use internal condom is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Clear Future, Inc..

When did Single-use internal condom receive FDA 510(k) clearance?

The clearance date for Single-use internal condom can be found in the official FDA records.

Who is the listed applicant for Single-use internal condom?

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

What is the FDA product code for Single-use internal condom?

The FDA product code for Single-use internal condom is MBU.

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_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related PubMed Literature

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.

PMID: 30272398Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom. Final order.Federal register ()

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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