meddevicedb.com FDA Device Reference

Breast Implant Removal Device (BIRD)

DEN220082 Class II Direct
Decision Date
2023-04-20
Sponsor / Applicant
Gaylord Solutions, LLC

Technical Specification

510(k) Submission ID DEN220082
Product Code QVS
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4675
Decision Date 2023-04-20
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Breast Implant Removal Device (BIRD) received FDA 510(k) clearance under submission number DEN220082, sponsored by Gaylord Solutions, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-04-20.

Classification & Regulation

This clearance is catalogued under FDA product code QVS and 21 CFR 878.4675, within the General, Plastic Surgery review panel as a Class II device.