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FDA PMA

Device, incontinence, mechanical/hydraulic

PMA Number: P000053 · 2026-09-14

ApplicantBoston Scientific Corp
Decision Date2026-09-14
PMA NumberP000053
Product CodeEZY
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeGU

Device Summary

Device, incontinence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code EZY. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Device, incontinence, mechanical/hydraulic?

Device, incontinence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.

When did Device, incontinence, mechanical/hydraulic receive FDA 510(k) clearance?

The clearance date for Device, incontinence, mechanical/hydraulic can be found in the official FDA records.

Who is the listed applicant for Device, incontinence, mechanical/hydraulic?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Device, incontinence, mechanical/hydraulic?

The FDA product code for Device, incontinence, mechanical/hydraulic is EZY.

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

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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