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FDA PMA

Test for Esophageal Varices

PMA Number: P220016 · 2026-06-18

ApplicantHepquant, LLC
Decision Date2026-06-18
PMA NumberP220016
Product CodeSIO
Advisory CommitteeCH

Device Summary

Test for Esophageal Varices is the device name listed in this FDA PMA record. The listed applicant is Hepquant, LLC. It received FDA Premarket Approval (PMA) on 2026-06-18 under PMA number P220016. The device is classified under FDA product code SIO. It was reviewed by the CH advisory panel. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Test for Esophageal Varices?

Test for Esophageal Varices is a medical device that received FDA Premarket Approval (PMA) on 2026-06-18. The listed applicant is Hepquant, LLC. The PMA number is P220016.

When did Test for Esophageal Varices receive FDA PMA approval?

Test for Esophageal Varices received FDA PMA approval on 2026-06-18, under PMA number P220016.

Who is the listed applicant for Test for Esophageal Varices?

The FDA PMA record lists Hepquant, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Test for Esophageal Varices?

The FDA product code for Test for Esophageal Varices is SIO.

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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