Pk Superpulse Sysem Generator Model 744000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100816 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PK SuperPulse System Generator Model 744000 is a versatile platform for urology and general surgical use that powers devices to cut, coagulate, and seal tissue. It utilizes pulsed, low-voltage RF energy to resect tissue rapidly at low temperatures, minimizing blood loss and shortening procedure times. The generator exploits the conductive properties of fluid used to distend the operative site.
The device requires standard non-electrolyte irrigation fluids used during conventional TURP to be replaced by normal saline. It is intended for use with Gyrus ACMI PK Bipolar Instruments, Olympus TURis Bipolar Electrodes, and PK Endourology Electrodes. The device has FDA 510(k) clearance with K number K100816.
Frequently asked questions
What is the PK SuperPulse System Generator Model 744000 used for?
The PK SuperPulse System Generator Model 744000 is a versatile platform for urology and general surgical use that powers devices to cut, coagulate, and seal tissue. It utilizes pulsed, low-voltage RF energy to resect tissue rapidly at low temperatures, minimizing blood loss and shortening procedure times.
What type of fluid is required for the PK SuperPulse System Generator Model 744000?
The device requires standard non-electrolyte irrigation fluids used during conventional TURP to be replaced by normal saline. This change is necessary because the generator exploits the conductive properties of the fluid used to distend the operative site.
Which instruments is the PK SuperPulse System Generator Model 744000 compatible with?
The device is intended for use with Gyrus ACMI PK Bipolar Instruments, Olympus TURis Bipolar Electrodes, and PK Endourology Electrodes. These compatible instruments work with the generator to perform various surgical procedures effectively.
What is the regulatory status of the PK SuperPulse System Generator Model 744000?
The PK SuperPulse System Generator Model 744000 has FDA 510(k) clearance with K number K100816. This means it has been determined to be substantially equivalent to legally marketed devices in the United States.
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: PK SuperPulse (744000) | Olympus America | Medical, Gyrus ACMI 744000 PlasmaKinetic SuperPulse Generator USER MANUAL, PK SUPERPULSE SYSEM GENERATOR MODEL 744000 (K100816) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100816 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K100816 24 fields · synced Sep 28, 2026