Disposable Suction and Irrigation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093479 FDA 510(k)
- FDA Product Code
- FHF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4370 FDA 510(k)
- Regulation Number
- 876.4370 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Disposable Suction and Irrigation System, classified as a System, Evacuator, Fluid under FDA nomenclature. It is designed for controlled aspiration and irrigation of bodily fluids during medical procedures, facilitating wound cleaning, cystoscopy, or endoscopic interventions in urology and gastroenterology.
The system is intended for single-use and comprises a stainless steel suction/irrigation probe connected to a handle with two trumpet-type valves. Supplied sterile and regulated under 21 CFR 876.4370, it is approved via FDA 510(k) clearance (K093479) as substantially equivalent to predicate devices. No third-party review is indicated, and the product code FHF identifies its classification within the regulatory framework.
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, DISPOSABLE SUCTION AND IRRIGATION SYSTEM 510(k) K093479 - fda.report, Modern Medical Equipment MFG. Ltd. 89055NS MEDLINE - RevMed, Medical Supply Company Portfolio I Medical Devices Showcase, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093479 | 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) K093479 24 fields · synced Oct 6, 2026