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Prizm Blade (moria Model) Lsk / Mk8510lsk +1 more model
FDA 510(k)Class I (US FDA 510(k))
510(k) K011195
Identifiers
- 510(k) Number
- K011195 FDA 510(k)
- FDA Product Code
- HNO FDA 510(k)
- Models / Variants
- Prizm Blade (moria Model) Lsk / Mk8510lsk FDA 510(k)Prizm Blade (moria Model) Cb / Mk8511cb 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)
Prizm Blade (moria Model) Lsk / Mk8510lsk +1 more model by Surgin Surgical Instrumentation, Inc. — Class I — FDA_510K — listed in FDA 510(k) — 2 models
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 | K011195 | Class I | Active |
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Manufacturer
- Manufacturer
- Surgin Surgical Instrumentation, Inc.
Sources (1)
- FDA 510(k) K011195 24 fields · synced Jun 18, 2026