Identifiers
- 510(k) Number
- K033003 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 Suction Coagulator is an electrosurgical device designed for cutting and coagulation procedures. It is intended for use in general and plastic surgery applications.
The device is supplied sterile and is intended for single use. It is MRI safe and available in various sizes. The device is regulated under FDA 510(k) clearance with product code GEI.
Frequently asked questions
What is the Suction Coagulator used for?
It is an electrosurgical device designed for cutting and coagulation procedures, intended for use in general and plastic surgery applications.
Is the Suction Coagulator sterile and single-use?
Yes, the device is supplied sterile and is intended for single use only.
Is the Suction Coagulator MRI safe?
Yes, the Suction Coagulator is MRI safe.
What is the regulatory status of the Suction Coagulator?
The device is regulated under FDA 510(k) clearance with product code GEI.
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: Quality Medical Equipment I Medical Supplies Hong Kong I MMEQ, Modern Medical Equipment MFG. Ltd. WA98421C Olympus, SUCTION COAGULATOR 510 (k) K033003 - FDA.report, MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD SUCTION COAG ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033003 | Class II | Active |
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Manufacturer
- Manufacturer
- Modern Medical Equipment MFG. Ltd.
- FDA Applicant
- Modern Medical Equipment Mfg., Ltd.
Sources (1)
- FDA 510(k) K033003 24 fields · synced Oct 6, 2026