Cleared Traditional

Ensizor Endoscopic Scissors

K150939 · Slater Endoscopy, LLC · Gastroenterology & Urology

Jun 2015

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K150939 is an FDA 510(k) clearance for the Ensizor Endoscopic Scissors, a Endoscopic Grasping/cutting Instrument, Non-powered (Class II — Special Controls, product code OCZ), submitted by Slater Endoscopy, LLC (Miami Lakes, US). The FDA issued a Cleared decision on June 8, 2015, 62 days after receiving the submission on April 7, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K150939 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2015
Decision Date	June 08, 2015
Days to Decision	62 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.