injeTAK Adjustable Tip Needle (DIS199; DIS201)— 510(k) K241523

Name: FDA 510(k) clearance K241523
Creator: U.S. Food and Drug Administration
Published: 2024-08-27

Substantially Equivalent

Laborie Medical Technologies, Corp.

FDA 510(k) clearance K241523 for injeTAK Adjustable Tip Needle (DIS199; DIS201), Substantially Equivalent on 2024-08-27. Applicant: Laborie Medical Technologies, Corp.. Device class: 2.

Clearance details

Applicant: Laborie Medical Technologies, Corp.
Product code: Code FBK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-29
Decision date: 2024-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Portsmouth, NH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.