510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810890Substantially Equivalent

Neoloops

Medical Marketing Systems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810890 is the FDA 510(k) clearance record for NEOLOOPS, a class I device, cleared for Medical Marketing Systems on under FDA product code DWS (Instruments, Surgical, Cardiovascular). FDA records list one 510(k) clearance for Medical Marketing Systems. As of , FDA records show no recalls naming K810890.

Clearance record

Decision date
Received
(151 days to decision)
Product code
DWS Instruments, Surgical, Cardiovascular
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Medical Marketing Systems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DWS

Trailing 12 months

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

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