Identifiers
- 510(k) Number
- K242857 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 ClearHemograsper is an Electric Biopsy Forceps (Product Code KGE), designed for precise hemostasis during surgical procedures. Its tapered tip and diamond-shaped design facilitate controlled tissue manipulation and bleeding control, particularly in delicate anatomical regions.
This device is supplied as a single-use, disposable instrument, intended for use in gastroenterology and urology procedures. It adheres to FDA 510(k) clearance (K242857) and MDR compliance, with no third-party reprocessing. Sterility and MRI safety are not specified, and storage conditions are manufacturer-dependent. The device is classified as Class II under regulation number 876.4300.
Frequently asked questions
What types of surgical procedures is the ClearHemograsper intended for, and how does its design support those uses?
The ClearHemograsper is designed specifically for gastroenterology and urology procedures, where precise hemostasis (bleeding control) is critical. Its tapered tip and diamond-shaped design allow for controlled tissue manipulation, reducing trauma to delicate anatomical regions while ensuring effective sealing of small vessels. This makes it particularly useful in minimally invasive surgeries where minimizing bleeding and tissue damage is essential.
Is the ClearHemograsper reusable, or is it intended for single-use only? What does this mean for my workflow?
The ClearHemograsper is explicitly supplied as a single-use, disposable instrument, with no third-party reprocessing allowed. This means each device is intended for one procedure only, reducing the risk of cross-contamination and ensuring consistent performance. Clinicians should follow manufacturer guidelines for disposal after use, which may impact workflow planning but aligns with best practices for infection control.
Are there multiple sizes or models of the ClearHemograsper, and if so, how do I determine which one to use?
The provided data does not specify individual sizes or model variants of the ClearHemograsper, but it is classified under Product Code KGE (Electric Biopsy Forceps) with multiple registration numbers (e.g., 3006546082, 1037905) in the FDA database. These registrations may correspond to different configurations or accessories. For precise sizing guidance, refer to the manufacturer’s product catalog or technical specifications, as the tapered tip and diamond-shaped design suggest variations may exist for different anatomical applications.
What storage conditions should I follow for the ClearHemograsper to maintain its integrity before use?
The data states that storage conditions are manufacturer-dependent, meaning Finemedix Co., Ltd. provides specific instructions (e.g., temperature, humidity, or packaging requirements) to ensure sterility and functionality. Always consult the accompanying documentation or the manufacturer’s website for detailed storage guidelines, as improper handling could compromise the device’s performance or sterility.
How do I confirm the regulatory compliance of the ClearHemograsper before purchasing or using it?
The ClearHemograsper holds FDA 510(k) clearance (K242857) and MDR compliance, indicating it meets U.S. and EU regulatory standards for electric biopsy forceps in gastroenterology and urology. To verify compliance, check the FDA’s OpenFDA database using the registration numbers (e.g., 3006546082) or review the device’s labeling for the FDA clearance number. For EU markets, ensure the MDR compliance is reflected in the CE marking, though this detail is not explicitly stated in the provided data.
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: ClearHemograsper - FINEMEDIX :: 파인메딕스, Finemedix Single-Use Clear Hemograsper - medical-xprt.com, ClearHemograsper (K242857) — FDA 510 (k) | Innolitics, K242857 - ClearHemograsper - Gastroenterology & Urology, ClearHemograsper (K242857) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242857 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (2)
- FDA 510(k) K242857 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026