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)

Allura Vaginal Stent

K-Number: K202542 · 2020-09-30

ApplicantPmt Corporation
Decision Date2020-09-30
Product CodeKXP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Allura Vaginal Stent is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corporation. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K202542. The device is classified under product code KXP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allura Vaginal Stent?

Allura Vaginal Stent is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Pmt Corporation. The 510(k) number is K202542.

When did Allura Vaginal Stent receive FDA 510(k) clearance?

Allura Vaginal Stent received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202542.

Who is the listed applicant for Allura Vaginal Stent?

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

What is the FDA product code for Allura Vaginal Stent?

The FDA product code for Allura Vaginal Stent is KXP.

Other records listing Pmt Corporation 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.

K151790PMT Platinum Depthalon Depth Electrode

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.

↑