Cleared Traditional

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

K242923 · Envision Endoscopy · Gastroenterology & Urology

Dec 2024

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K242923 is an FDA 510(k) clearance for the SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230), a Endoscopic Grasping/cutting Instrument, Non-powered (Class II — Special Controls, product code OCZ), submitted by Envision Endoscopy (Waltham, US). The FDA issued a Cleared decision on December 20, 2024, 87 days after receiving the submission on September 24, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K242923 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2024
Decision Date	December 20, 2024
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCZ — Endoscopic Grasping/cutting Instrument, Non-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.