Cleared Traditional

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

K232633 · Boston Scientific · Gastroenterology & Urology

Nov 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K232633 is an FDA 510(k) clearance for the Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Boston Scientific (Marborough, US). The FDA issued a Cleared decision on November 28, 2023, 90 days after receiving the submission on August 30, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number	K232633 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2023
Decision Date	November 28, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.4300