Ensure Single-Use Coagulation Forceps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202438 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 Ensure Single-Use Coagulation Forceps are single-use, electric forceps designed for targeted coagulation of bleeding vessels during endoscopic procedures. Classified as Forceps, Biopsy, Electric (product code KGE), these devices deliver monopolar coagulation to achieve hemostasis in gastrointestinal (GI) and urological applications. Their design enables precise vessel isolation and controlled tissue sealing, reducing bleeding risks during interventions.
These forceps are intended for single-use in sterile environments and are supplied ready for immediate clinical application. They are classified as Class II medical devices under FDA regulations (876.4300) and have received FDA 510(k) clearance (K202438). The devices feature a 360° bidirectional rotation mechanism for enhanced maneuverability. Storage instructions and MRI safety are not specified in the available data, but they are intended for use in endoscopy suites and urology procedures as per advisory committee classifications.
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: ENSURE COAGULATION FORCEPS - Micro-Tech Endoscopy, Ensure - Micro-tech Europe, K202438 FDA 510 (k) - Ensure Single-Use Coagulation Forceps
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202438 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA 510(k) K202438 24 fields · synced Sep 20, 2026