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
K923681Substantially Equivalent

Exonox Percutaneous Introducer System W/ Hemostasi

Exonix Research Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923681 is the FDA 510(k) clearance record for EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI, a class II device, cleared for Exonix Research Corp. on under FDA product code DYB (Introducer, Catheter). FDA records list 2 510(k) clearances for Exonix Research Corp., from to . As of , FDA records show no recalls naming K923681.

Clearance record

Decision date
Received
(183 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Exonix Research Corp. 9344 NW 13 St., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260