510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843941Substantially Equivalent

Endocyte

Gyneco, Inc., Flemington NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843941 is the FDA 510(k) clearance record for ENDOCYTE, a class II device, cleared for Gyneco, Inc. on under FDA product code HFE (Brush, Endometrial). FDA records list 5 510(k) clearances for Gyneco, Inc., from to . As of , FDA records show no recalls naming K843941.

Clearance record

Decision date
Received
(139 days to decision)
Product code
HFE Brush, Endometrial
Regulation
21 CFR 884.1100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gyneco, Inc. 12 Minneakoning Rd., Flemington NJ
Third party review
No

Clearances, product code HFE

Trailing 12 months

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

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