510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982472Substantially Equivalent

Genicon Trocar

Genicon, LC, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982472 is the FDA 510(k) clearance record for GENICON TROCAR, a class I device, cleared for Genicon, LC on under FDA product code GEA (Cannula, Surgical, General & Plastic Surgery). FDA records list 6 510(k) clearances for Genicon, LC, from to . As of , FDA records show 15 recalls naming K982472.

Clearance record

Decision date
Received
(204 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
Genicon, LC 573 Waterscape Way, Orlando FL
510(k) summary
Summary
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