510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K941678Substantially Equivalent

Bionector

Vygon Corp., East Rutherford NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941678 is the FDA 510(k) clearance record for BIONECTOR, a class II device, cleared for Vygon Corp. on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 13 510(k) clearances for Vygon Corp., from to . As of , FDA records show no recalls naming K941678.

Clearance record

Decision date
Received
(447 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Vygon Corp. One Madison St., East Rutherford NJ
510(k) summary
Statement
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260