Ensizor Endoscopic Scissors
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ENSIZOR EUDAMEDFDA UDI
- Generic Name
- Flexible endoscopic scissors, single-use FDA UDI
- Device Name
- Ensizor Endoscopic Scissors EUDAMEDFlexible endoscopic scissors FDA UDI
- Model / Reference
- ES26235 EUDAMEDFDA UDIES26235-1 EUDAMED
- Description
- Flexible endoscopic scissors FDA UDI
Identifiers
- Catalog Number
- ES26235-1 FDA UDI
- Primary DI / UDI-DI
- 00860001219821 EUDAMEDFDA UDI
- Basic UDI-DI
- 860001219807ES26235SC EUDAMED
- 510(k) Number
- K141058 FDA 510(k)
- FDA Product Code
- OCZ FDA 510(k)FDA UDI
- EMDN Code
- K01020102 MINIMALLY INVASIVE SURGERY SCISSORS, SINGLE-USE EUDAMED
- GMDN Term
- Flexible endoscopic scissors, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 235 Centimeter FDA UDIOuter Diameter — 2.6 Millimeter FDA UDI
The Ensizor Endoscopic Scissors are a non-powered endoscopic grasping and cutting instrument designed for use in minimally invasive procedures. Classified as an endoscopic grasping/cutting device, they are intended for precise tissue manipulation and sectioning during endoscopic examinations, particularly in gastroenterology and urology.
These scissors are supplied sterile for single-use and are regulated under FDA 510(k) clearance (K141058) and MDR compliance. They are manufactured by Slater Endoscopy, LLC, and are available in multiple reference codes as listed in the registration database. The device is intended for use in controlled clinical settings, adhering to standard endoscopic protocols, and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What specialties are the Ensizor Endoscopic Scissors primarily intended for in clinical practice?
The Ensizor Endoscopic Scissors are designed for use in gastroenterology and urology procedures, as indicated by their classification as an endoscopic grasping/cutting device and the advisory committee descriptions (Gastroenterology, Urology). They are intended for precise tissue manipulation and sectioning during minimally invasive endoscopic examinations in these specialties.
Are the Ensizor Endoscopic Scissors reusable or single-use, and how should they be stored?
The Ensizor Endoscopic Scissors are sterile for single-use only. To maintain sterility and functionality, they must be stored according to the manufacturer’s instructions, which likely include keeping them in a sealed, sterile packaging until use and avoiding exposure to contaminants or moisture.
How do I identify the correct model or reference code for the Ensizor Endoscopic Scissors I need?
The Ensizor Endoscopic Scissors come in multiple reference codes, as listed in the regulatory database (e.g., 3006546082, 1220592, etc.). These codes are tied to specific product variations, so you should verify the exact code required for your procedure or facility by checking the manufacturer’s documentation or contacting Slater Endoscopy, LLC directly.
What regulatory pathway was followed for the FDA clearance of the Ensizor Endoscopic Scissors?
The Ensizor Endoscopic Scissors received FDA 510(k) clearance (K141058) under a traditional review process, with a decision date of August 1, 2014. The device was determined to be substantially equivalent to a predicate, meaning it met the FDA’s requirements for safety and effectiveness in its intended use as an endoscopic grasping/cutting instrument.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141058 | Class II | Active |
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Manufacturer
- Manufacturer
- Slater Endoscopy, LLC
Sources (3)
- FDA 510(k) K141058 24 fields · synced Sep 18, 2026
- FDA UDI 44e1776b-0c94-4a49-a469-48c9186e7e42 35 fields · synced May 30, 2026
- EUDAMED f9ed69c7-50e2-420b-bef5-ce93f7c4c9b1 61 fields · synced Jul 15, 2026