510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163597Substantially Equivalent

VacLok AT Vacuum Syringe

Merit Medical Systems, Inc., South Jordan UT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163597 is the FDA 510(k) clearance record for VacLok AT Vacuum Syringe, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code PUR (Vacuum Syringe). FDA's definition for product code PUR reads: "The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess...". FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K163597.

Clearance record

Decision date
Received
(218 days to decision)
Product code
PUR Vacuum Syringe
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PUR

Trailing 12 months

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

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