Ensizor Endoscopic Scissors

FDA 510(k) K150939 · Slater Endoscopy, LLC

Substantially Equivalent

510(k) numberK150939

Submission

Device name
Ensizor Endoscopic Scissors
Applicant
Slater Endoscopy, LLC
Miami Lakes, FL, US
Received
April 7, 2015
Decision date
June 8, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Other 510(k)s with product code OCZ

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K252800KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional Karl Storz SE & CO. KG06/03/2026SE
K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…OCZ · Traditional Envision Endoscopy12/20/2024SE
K191900Single Use Grasping ForcepsOCZ · Traditional Zhejiang Chuangxiang Medical Technology Co., Ltd.03/27/2020SE
K152802Grasping ForcepsOCZ · Traditional Micro-Tech (Nanjing) Co., Ltd.01/21/2016SE
K141058Ensizor Endoscopic ScissorsOCZ · Traditional Slater Endoscopy, LLC08/01/2014SE
K133736Endoscopic Suture CutterOCZ · Traditional United States Endoscopy Group, Inc.01/07/2014SE
K120084Endoscopic Retrieval DeviceOCZ · Traditional United States Endoscopy Group, Inc.05/30/2012SE
K103688G-Prox Ez Endoscopic GrasperOCZ · Special Usgi Medical01/14/2011SE
K101298Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional Endochoice, Inc.08/05/2010SE
K072684Mondeal Endoscopic Tissue Recession and Release SystemOCZ · Traditional Mondeal North America, Inc.01/04/2008SE

More from Mondeal North America, Inc.

510(k)DeviceDecision
K180134Ensizor Monopolar Endoscopic ScissorsKGE · Traditional 06/29/2018SE
K141058Ensizor Endoscopic ScissorsOCZ · Traditional 08/01/2014SE

Questions and answers

When was Ensizor Endoscopic Scissors cleared by the FDA?

Ensizor Endoscopic Scissors (K150939) received a 510(k) decision of Substantially Equivalent on June 8, 2015, 62 days after the submission was received.

What is the product code of K150939?

The FDA product code is OCZ – Endoscopic Grasping/Cutting Instrument, Non-Powered, a Class II (moderate risk) device regulated under 21 CFR 876.1500.