510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220082Unknown

Breast Implant Removal Device (BIRD)

Gaylord Solutions, LLC, Gaylord MI / Direct, Unknown
FDA source (opens on fda.gov)

DEN220082 is the FDA 510(k) clearance record for Breast Implant Removal Device (BIRD), a class II device, cleared for Gaylord Solutions, LLC on under FDA product code QVS (Breast Implant Suction Retrieval Device). FDA's definition for product code QVS reads: "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". FDA records list one 510(k) clearance for Gaylord Solutions, LLC. As of , FDA records show no recalls naming DEN220082.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QVS Breast Implant Suction Retrieval Device
Regulation
21 CFR 878.4675
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gaylord Solutions, LLC 1258 Old 27 N, Gaylord MI
Third party review
No

Clearances, product code QVS

Trailing 12 months
1 clearance under product code QVS in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260