510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914496Substantially Equivalent

Sclerotherapy Needle

Surgitek Medical Engineering Corp., Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914496 is the FDA 510(k) clearance record for SCLEROTHERAPY NEEDLE, a class II device, cleared for Surgitek Medical Engineering Corp. 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 11 510(k) clearances for Surgitek Medical Engineering Corp., from to . As of , FDA records show no recalls naming K914496.

Clearance record

Decision date
Received
(58 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
Surgitek Medical Engineering Corp. 3037 Mt. Pleasant St., Racine WI
510(k) summary
Summary
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