Stingray Ultralite Disposable Irrigating Bipolar Forceps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102752 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 Stingray Ultralite Disposable Irrigating Bipolar Forceps is a disposable electrosurgical device used for bipolar coagulation during surgical procedures. It features an ultra light design with silver alloy non-stick tips and a stop guide to reduce scissoring effects on the handle. The device is designed for use with bipolar coagulation current activated by a footswitch through an electrosurgical generator unit.
This disposable forceps is supplied with an irrigation port and is intended for single-use applications. It is manufactured by Stingray Surgical Products and has received FDA 510(k) clearance with the product code GEI. The device is not MRI compatible and should be stored according to the manufacturer's instructions.
Frequently asked questions
What is the Stingray Ultralite Disposable Irrigating Bipolar Forceps used for?
The Stingray Ultralite Disposable Irrigating Bipolar Forceps is a disposable electrosurgical device used for bipolar coagulation during surgical procedures. It features an ultra light design with silver alloy non-stick tips and a stop guide to reduce scissoring effects on the handle.
Is the Stingray Ultralite Bipolar Forceps reusable or single-use?
The Stingray Ultralite Disposable Irrigating Bipolar Forceps is intended for single-use applications only. It is supplied with an irrigation port and should not be reused according to the manufacturer's instructions.
What are the key features of the Stingray Ultralite Bipolar Forceps?
The device features an ultra light design with silver alloy non-stick tips and a stop guide to reduce scissoring effects on the handle. It is designed for use with bipolar coagulation current activated by a footswitch through an electrosurgical generator unit.
What is the regulatory status of the Stingray Ultralite Bipolar Forceps?
The Stingray Ultralite Disposable Irrigating Bipolar Forceps has received FDA 510(k) clearance with the product code GEI. It is manufactured by Stingray Surgical Products and is not MRI compatible.
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: Disposable Bipolar Forceps - Stingray Surgical Products, Stingray Ultralite Disposable Irrigating Bipolar Forceps, Bipolar Forceps | Stingray Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102752 | Class II | Active |
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Manufacturer
- Manufacturer
- Stingray Surgical Products
- FDA Applicant
- Stingray Surgical Products, Inc.
Sources (1)
- FDA 510(k) K102752 24 fields · synced Sep 26, 2026