510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K902197Substantially Equivalent

Fujinon Evl-F (Tentative) and Trocar

FUJIFILM Healthcare Americas Corporation, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902197 is the FDA 510(k) clearance record for FUJINON EVL-F (TENTATIVE) AND TROCAR, a class II device, cleared for Fujinon, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K902197.

Clearance record

Decision date
Received
(293 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Fujinon, Inc. Suite 750, Washington DC
Third party review
No

Clearances, product code HET

Trailing 12 months

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

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