Unipolar Optical Biopsy Forceps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K983811 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 Unipolar Optical Biopsy Forceps is a type of forceps used for biopsy procedures, classified as an electric biopsy forceps. It is used in medical specialties such as gastroenterology and urology. The device is designed to facilitate the collection of tissue samples for examination. It is an example of a medical device used in minimally invasive procedures.
The Unipolar Optical Biopsy Forceps is supplied as a single device and is intended for use in a clinical setting. The device is regulated under the FDA's 510K clearance process and has been assigned a regulation number of 876.4300. It is classified as a class 2 device. The device is used in procedures where a biopsy is required, and its use is subject to the relevant medical guidelines and protocols.
Frequently asked questions
What is the Unipolar Optical Biopsy Forceps used for?
The Unipolar Optical Biopsy Forceps is used for biopsy procedures in medical specialties such as gastroenterology and urology to collect tissue samples for examination.
Is the Unipolar Optical Biopsy Forceps supplied sterile?
The device data does not explicitly state that the Unipolar Optical Biopsy Forceps is supplied sterile, but it is intended for use in a clinical setting where sterility is typically required.
Is the Unipolar Optical Biopsy Forceps a single-use device?
The Unipolar Optical Biopsy Forceps is supplied as a single device, but the device data does not explicitly state whether it is intended for single-use or reuse.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983811 | Class II | Active |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA 510(k) K983811 24 fields · synced Sep 23, 2026