Identifiers
- 510(k) Number
- K781353 FDA 510(k)
- FDA Product Code
- KNS 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)
A papillotome cutting snare is a unit, electrosurgical, endoscopic device (with or without accessories) used in gastroenterology and urology procedures. It is designed for cutting and removing tissue during endoscopic interventions.
The device is supplied as a reusable instrument and requires proper cleaning and sterilization between uses. It is regulated under FDA 510(k) clearance K781353, with product code KNS and regulation number 876.4300, and is classified as a Class II medical device.
Frequently asked questions
What is the purpose of the papillotome cutting snare?
The papillotome cutting snare is a unit, electrosurgical, endoscopic device used in gastroenterology and urology procedures for cutting and removing tissue during endoscopic interventions.
Is the papillotome cutting snare reusable or single-use?
The device is supplied as a reusable instrument and requires proper cleaning and sterilization between uses.
What are the regulatory details for this device?
The papillotome cutting snare is regulated under FDA 510(k) clearance K781353, with product code KNS and regulation number 876.4300, classified as a Class II medical device.
In which medical specialties is this device used?
The papillotome cutting snare is used in gastroenterology and urology procedures for cutting and removing tissue during endoscopic interventions.
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. Sources consulted: PAPILLOTOME CUTTING SNARE (K781353) — FDA 510(k) | Innolitics, PAPILLOTOME CUTTING SNARE 510 (k) K781353 - FDA.report, Cameron-Miller, Inc. - Chicago, Illinois (IL) @ MedicRegister.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K781353 | Class II | Active |
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Manufacturer
- Manufacturer
- Cameron-Miller, Inc.
Sources (1)
- FDA 510(k) K781353 24 fields · synced Sep 19, 2026