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
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K020891Substantially Equivalent

Nakao Snare II and Nakao Snare III

Granit Medical Innovations, New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020891 is the FDA 510(k) clearance record for NAKAO SNARE II AND NAKAO SNARE III, a class II device, cleared for Granit Medical Innovations on under FDA product code FDI (Snare, Flexible). FDA records list one 510(k) clearance for Granit Medical Innovations. As of , FDA records show no recalls naming K020891.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Granit Medical Innovations 992 Fifth Ave., New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDI

Trailing 12 months
1 clearance under product code FDI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260