Identifiers
- 510(k) Number
- K180640 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SmartClip Soft Tissue Marker is a reliable and accurate soft tissue marker used in general plastic surgery to guide precise incisions. This device offers a unique combination of high-precision tip movement, intuitive ergonomic design, and easy-to-use interface, making it an essential tool for surgeons and healthcare professionals.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180640 | Class II | Active |
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Manufacturer
- Manufacturer
- Elucent Medical, Inc.
Sources (1)
- FDA 510(k) K180640 24 fields · synced Jun 30, 2026