← Back to catalogue
Accublade (acs Model), Mk8507, Accublade (hansotome Model), Mk8508
FDA 510(k)Class I (US FDA 510(k))
510(k) K994015
Identifiers
- 510(k) Number
- K994015 FDA 510(k)
- FDA Product Code
- HNO FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4370 FDA 510(k)
- Regulation Number
- 886.4370 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Accublade (acs Model), Mk8507, Accublade (hansotome Model), Mk8508 by Surgin Surgical Instrumentation, Inc. — Class I — FDA_510K — listed in FDA 510(k)
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 | K994015 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgin Surgical Instrumentation, Inc.
Sources (1)
- FDA 510(k) K994015 24 fields · synced Jun 18, 2026