Ensizor Monopolar Endoscopic Scissors
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180134 FDA 510(k)
- FDA Product Code
- KGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4300 FDA 510(k)
- Regulation Number
- 876.4300 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ensizor Monopolar Endoscopic Scissors are a class II electric biopsy forceps designed for endoscopic procedures. These scissors deliver monopolar electrosurgical current to cut and coagulate tissue during minimally invasive gastrointestinal or urological examinations, facilitating precise tissue sampling and hemostasis.
Supplied as a reusable device, the Ensizor Monopolar Endoscopic Scissors are intended for use in controlled clinical settings such as operating rooms or endoscopy suites. They are regulated under FDA 510K clearance (K180134) and the EU MDR, with a registration number of 3006546082 among others. Compatible with standard endoscopic systems, these scissors require proper sterilization between uses and adherence to electrosurgical safety protocols, including MRI non-ferromagnetic construction.
Frequently asked questions
Are the Ensizor Monopolar Endoscopic Scissors designed for single-use or can they be reused after sterilization?
The Ensizor Monopolar Endoscopic Scissors are supplied as a reusable device, requiring proper sterilization between uses. This design aligns with their use in controlled clinical settings like operating rooms or endoscopy suites, where rigorous sterilization protocols are standard.
What medical specialties are these scissors primarily intended for, and how does that influence their use?
The scissors are primarily intended for use in gastroenterology and urology procedures, as indicated by their advisory committee classification (GU) and medical specialty descriptions. This means they are specifically engineered for minimally invasive endoscopic surgeries in the gastrointestinal and urological systems, such as tissue sampling or hemostasis during biopsies.
Do these scissors require any special handling or storage conditions, and why?
While the device data does not specify exact storage conditions, as a reusable electrosurgical tool with MRI non-ferromagnetic construction, it must be stored in a clean, dry environment to prevent contamination or damage. Proper handling is critical due to their monopolar electrosurgical function, which requires adherence to safety protocols to avoid unintended tissue damage or equipment failure.
Are there multiple sizes or models of the Ensizor Monopolar Endoscopic Scissors, and if so, how would a clinician determine the right fit for their procedure?
The provided data does not list specific sizes or model variations, but the scissors are designed for endoscopic procedures, suggesting compatibility with standard endoscopic systems. Clinicians should consult the manufacturer’s documentation or technical specifications for exact sizing details, as the appropriate choice may depend on the procedure type (e.g., gastrointestinal vs. urological) and the specific endoscopic instrument channel being used.
What regulatory pathways have been followed for the Ensizor Monopolar Endoscopic Scissors, and how does that affect their availability?
The scissors have undergone FDA 510(k) clearance (K180134) and comply with the EU MDR (registration number 3006546082), confirming their regulatory approval for use in the U.S. and European markets. This means they are legally available for purchase and use in these regions, provided they are used within their intended clinical settings and sterilization protocols.
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 | K180134 | Class II | Active |
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Manufacturer
- Manufacturer
- Slater Endoscopy, LLC
Sources (2)
- FDA 510(k) K180134 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026