510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K150891Substantially Equivalent

BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

Covidien, LLC( Formerly Beacon Endoscopic Corp.), Mansfield MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150891 is the FDA 510(k) clearance record for BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System, a class II device, cleared for Covidien, LLC( Formerly Beacon Endoscopic Corp.) on under FDA product code FCG (Biopsy Needle). FDA records list 2 510(k) clearances for Covidien, LLC( Formerly Beacon Endoscopic Corp.), from to . As of , FDA records show no recalls naming K150891.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Covidien, LLC( Formerly Beacon Endoscopic Corp.) 15 Hamshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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