510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070918Substantially Equivalent

4Ddome

Cousin Biotech, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070918 is the FDA 510(k) clearance record for 4DDOME, a class II device, cleared for Cousin Biotech on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list one 510(k) clearance for Cousin Biotech. As of , FDA records show no recalls naming K070918.

Clearance record

Decision date
Received
(142 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cousin Biotech 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTL

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