510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934970Substantially Equivalent

Duet

Trulife, Inc., Dublin 24, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934970 is the FDA 510(k) clearance record for DUET, a class I device, cleared for Trulife , Ltd. on under FDA product code GBJ (Prosthesis, Adhesive, External). FDA records list one 510(k) clearance for Trulife , Ltd. As of , FDA records show no recalls naming K934970.

Clearance record

Decision date
Received
(53 days to decision)
Product code
GBJ Prosthesis, Adhesive, External
Regulation
21 CFR 878.3750
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Trulife , Ltd. 3 Cookstown Industrial Estate, Dublin 24, IE
510(k) summary
Statement
Third party review
No

Clearances, product code GBJ

Trailing 12 months

FDA records hold no clearances under product code GBJ in the trailing twelve months.

FDA records show no clearances under product code GBJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GBJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260