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FDA 510(k)

Relieva Tract Balloon Dilation System

K-Number: K183090 · 2019-04-19

ApplicantAcclarent, Inc.
Decision Date2019-04-19
Product CodeQGK
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Relieva Tract Balloon Dilation System is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K183090. The device is classified under product code QGK. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Relieva Tract Balloon Dilation System?

Relieva Tract Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Acclarent, Inc.. The 510(k) number is K183090.

When did Relieva Tract Balloon Dilation System receive FDA 510(k) clearance?

Relieva Tract Balloon Dilation System received FDA 510(k) clearance on 2019-04-19, under 510(k) number K183090.

Who is the listed applicant for Relieva Tract Balloon Dilation System?

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

What is the FDA product code for Relieva Tract Balloon Dilation System?

The FDA product code for Relieva Tract Balloon Dilation System is QGK.

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.

NCT07759752Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPHNOT_YET_RECRUITING

Other records listing Acclarent, Inc. 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.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi Curette

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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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