Not Cleared Direct

DEN220082 - Breast Implant Removal Device (BIRD) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220082 · Gaylord Solutions, LLC · General & Plastic Surgery device
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Apr 2023
Decision
150d
Days
Class 2
Risk

DEN220082 is an FDA 510(k) submission (not cleared) for the Breast Implant Removal Device (BIRD). Classified as Breast Implant Suction Retrieval Device (product code QVS), Class II - Special Controls.

Submitted by Gaylord Solutions, LLC (Gaylord, US). The FDA issued a Not Cleared (DENG) decision on April 20, 2023 after a review of 150 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4675 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

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Submission Details

510(k) Number DEN220082 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 21, 2022
Decision Date April 20, 2023
Days to Decision 150 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 114d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QVS Breast Implant Suction Retrieval Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4675
Definition A Breast Implant Suction Retrieval System Is A Prescription Surgical Device That Uses Vacuum Suction To Assist In The Removal And Containment Of A Ruptured Silicone Breast Implant.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.