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paediscope model p010a and pf011a
Aesculap
Summary: The Paediscope models P010A and PF011A by Aesculap are devices used in prostate-artery-embolization procedures. Cleared by the FDA via the 510k pathway, these devices are supported by 10 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K014149 ↗
Decision Date
March 18, 2002
Product Code
GWG
Device Class
Class 2
Evidence
0 studies
The Paediscope models P010A and PF011A were cleared by the FDA through the 510k pathway on March 18, 2002. Manufactured by Aesculap, these devices are classified as Class 2 under product code GWG.
What It Is
The Paediscope models P010A and PF011A are medical devices designed for use in prostate-artery-embolization procedures. These devices facilitate the embolization process, which is intended to reduce blood flow to the prostate, thereby alleviating symptoms associated with prostate enlargement.
Clinical Applications
These devices are commonly used in interventional radiology settings for patients undergoing prostate-artery-embolization. They are particularly useful in cases where traditional surgical interventions are not suitable or desired.
Evidence Summary
The available literature includes 10 studies, though specific details on study types, sample sizes, and outcomes are not provided in the evidence. The studies span a range of years, with the most recent being from 2024.
Reported Outcomes
Published studies report limited specific outcomes related to the efficacy of the Paediscope models P010A and PF011A in prostate-artery-embolization. The evidence provided does not include detailed efficacy findings.
Safety Profile
Reported complications include limited safety data from the provided evidence. Specific adverse events or complications related to the use of these devices in clinical settings are not detailed in the available studies.
Evidence Limitations
The evidence lacks detailed information on study outcomes, safety data, and specific clinical efficacy. Further research is needed to better understand the long-term effectiveness and safety profile of these devices in prostate-artery-embolization.
Frequently Asked Questions
What are the clinical indications for paediscope models P010A and PF011A?
These devices are indicated for use in prostate-artery-embolization procedures to manage symptoms of prostate enlargement.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, and outcomes related to efficacy are not provided in the available studies.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications detailed in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.