Cleared Special

injeTAK Adjustable Tip Needle (DIS199; DIS201)

K241523 · Laborie Medical Technologies, Corp. · Gastroenterology & Urology
Aug 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K241523 is an FDA 510(k) clearance for the injeTAK Adjustable Tip Needle (DIS199; DIS201), a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Laborie Medical Technologies, Corp. (Portsmouth, US). The FDA issued a Cleared decision on August 27, 2024, 90 days after receiving the submission on May 29, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K241523 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2024
Decision Date August 27, 2024
Days to Decision 90 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FBK — Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.

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