Cleared Special

Bendit17 Microcatheter

K252213 · Bend IT Technologies, Ltd. · Neurology
Dec 2025
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K252213 is an FDA 510(k) clearance for the Bendit17 Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Bend IT Technologies, Ltd. (Petach Tikva, IL). The FDA issued a Cleared decision on December 3, 2025, 141 days after receiving the submission on July 15, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K252213 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2025
Decision Date December 03, 2025
Days to Decision 141 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QJP — Catheter, Percutaneous, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures