Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213831 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 Olympus PK Electrosurgical Instruments—PK J-Hook, PK Spatula, and PK Needle—are electrosurgical tools designed for cutting and coagulation of tissue using high-frequency electrical current. These instruments are classified as electrosurgical accessories, intended for use with compatible generators to facilitate precise surgical procedures in general and plastic surgery settings.
These instruments are supplied as reusable medical devices and are intended for use in controlled surgical environments. They are compatible with the Olympus ESG-400 and ESG-410 generators and have been cleared under FDA 510(k) as substantially equivalent to prior-generation devices. No specific sterility or MRI safety information is provided in the regulatory data, and sizes or additional technical specifications are not detailed beyond their classification as electrosurgical accessories.
Frequently asked questions
What are the Olympus PK Electrosurgical Instruments used for?
These instruments are designed for cutting and coagulation of tissue using high-frequency electrical current in general and plastic surgery settings when used with compatible generators.
Are the Olympus PK Electrosurgical Instruments reusable or single-use?
These instruments are supplied as reusable medical devices intended for use in controlled surgical environments.
Which generators are compatible with the Olympus PK Electrosurgical Instruments?
These instruments are compatible with the Olympus ESG-400 and ESG-410 generators.
What is the regulatory status of the Olympus PK Electrosurgical Instruments?
The instruments have been cleared under FDA 510(k) as substantially equivalent to prior-generation devices.
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: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK ..., PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook, Olympus – Wikipedia, PK Technology Bipolar Energy System | Gynecology - Olympus
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213831 | Class II | Active |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K213831 24 fields · synced Sep 19, 2026