510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854005Substantially Equivalent for Some Indications

Dedo Suction Cannula

Dedo Manufacturer, Inc., West Palm Beach FL / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K854005 is the FDA 510(k) clearance record for DEDO SUCTION CANNULA, a class I device, cleared for Dedo Manufacturer, Inc. on under FDA product code GEA (Cannula, Surgical, General & Plastic Surgery). FDA records list one 510(k) clearance for Dedo Manufacturer, Inc. As of , FDA records show no recalls naming K854005.

Clearance record

Decision date
Received
(67 days to decision)
Product code
GEA Cannula, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dedo Manufacturer, Inc. 1515 N. Flagler Dr., West Palm Beach FL
Third party review
No

Clearances, product code GEA

Trailing 12 months

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

FDA records show no clearances under product code GEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEA, 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