FDA 510(k)

Soft Palate Elevator

K-Number: K222127 · 2022-10-24

Decision Date2022-10-24

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Soft Palate Elevator is the device name listed in this FDA 510(k) record. The listed applicant is The Tmj Clinic PC. It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K222127. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soft Palate Elevator?

Soft Palate Elevator is a medical device that received FDA 510(k) clearance on 2022-10-24. The listed applicant is The Tmj Clinic PC. The 510(k) number is K222127.

When did Soft Palate Elevator receive FDA 510(k) clearance?

Soft Palate Elevator received FDA 510(k) clearance on 2022-10-24, under 510(k) number K222127.

Who is the listed applicant for Soft Palate Elevator?

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

What is the FDA product code for Soft Palate Elevator?

The FDA product code for Soft Palate Elevator is LRK.

Other records listing The Tmj Clinic PC 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.