510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K222006Substantially Equivalent

Sclerotherapy & Endoscopic Needles

G-Flex Europe Sprl, Nivelles, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222006 is the FDA 510(k) clearance record for Sclerotherapy & Endoscopic Needles, a class II device, cleared for G-Flex Europe Sprl on under FDA product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology). FDA's definition for product code FBK reads: "inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue". FDA records list 2 510(k) clearances for G-Flex Europe Sprl, from to . As of , FDA records show no recalls naming K222006.

Clearance record

Decision date
Received
(270 days to decision)
Product code
FBK Endoscopic Injection Needle, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
G-Flex Europe Sprl 20, Rue De L’Industrie, Nivelles, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FBK

Trailing 12 months
3 clearances under product code FBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260