510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031238Substantially Equivalent

Varices Needle

Scandimed. A.S., Collegeville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031238 is the FDA 510(k) clearance record for VARICES NEEDLE, a class II device, cleared for Scandimed. A.S. 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 Scandimed. A.S., from to . As of , FDA records show no recalls naming K031238.

Clearance record

Decision date
Received
(535 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
Scandimed. A.S. 280 Godshall Rd., Collegeville PA
510(k) summary
Statement
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