Creo Electrosurgical System with HS1 Hemostasis Accessory
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192905 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
- SESK Substantially Equivalent — Kit FDA 510(k)
The Creo Electrosurgical System with HS1 Hemostasis Accessory is a unit electrosurgical endoscopic device, with or without accessories, designed to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation, hemostasis, and cauterization of soft tissue. It is intended for use only with compatible Creo Medical instruments and accessories, and the HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy.
The device is supplied as a system comprising a generator and accessory, and is authorized under FDA 510(k) clearance K192905 with product code KNS and regulation number 876.4300. It is classified as a Class II device, with a traditional clearance type, and was determined to be substantially equivalent (SESK) on March 19, 2020. The device is used in gastroenterology and urology settings, and its specifications include the exact model designation and manufacturer details as provided.
Frequently asked questions
What is the Creo Electrosurgical System with HS1 Hemostasis Accessory used for?
It is designed to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation, hemostasis, and cauterization of soft tissue during endoscopic procedures, specifically intended for use with compatible Creo Medical instruments and accessories, including the HS1 Hemostasis Accessory for endoscopic injection therapy.
How is the Creo Electrosurgical System with HS1 Hemostasis Accessory supplied?
The device is supplied as a complete system comprising a generator and the HS1 Hemostasis Accessory, intended for use together as a unit in endoscopic settings such as gastroenterology and urology.
Is the Creo Electrosurgical System with HS1 Hemostasis Accessory reusable or single-use?
The device data does not specify whether the system or its accessories are single-use or reusable; therefore, reuse status cannot be determined from the provided information and should be confirmed in the manufacturer’s instructions for use.
What regulatory authorization does the Creo Electrosurgical System with HS1 Hemostasis Accessory have?
The device is authorized under FDA 510(k) clearance K192905, with product code KNS and regulation number 876.4300, and was determined to be substantially equivalent on March 19, 2020, as a Class II device with traditional clearance.
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: Creo Electrosurgical System with HS1 Hemostasis Accessory, Creo Electrosurgical System With HS1 Hemostasis… - FDA.report, Creo Electrosurgical System with HS1 Hemostasis Accessory
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192905 | Class II | Active |
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Manufacturer
- Manufacturer
- Creo Medical, Ltd.
Sources (1)
- FDA 510(k) K192905 24 fields · synced Sep 24, 2026