510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061497Substantially Equivalent

Syrex Heparin Lock Flush Syringe, 1 Unit/ml & 2 Units/ml

Excelsior Medical LLC, Neptune NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061497 is the FDA 510(k) clearance record for SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML, a class II device, cleared for Excelsior Medical Corp. on under FDA product code NZW (Heparin, Vascular Access Flush). FDA's definition for product code NZW reads: "Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use". FDA records list 11 510(k) clearances for Excelsior Medical Corp., from to . As of , FDA records show 13 recalls naming K061497.

Clearance record

Decision date
Received
(268 days to decision)
Product code
NZW Heparin, Vascular Access Flush
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Excelsior Medical Corp. 1933 Heck Ave., Neptune NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZW

Trailing 12 months

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

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