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Tricera Arthroscopic System - Curved Standard Shaver 3.4mm (R-10024)
FDA 510(k)Class II (US FDA 510(k))
510(k) K233493
Identifiers
- 510(k) Number
- K233493 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- Tricera Arthroscopic System FDA 510(k)Tricera Controller (R-10001) FDA 510(k)Tricera Shaver Handpiece (R-10023) FDA 510(k)Veriflow (R-10003) FDA 510(k)Exoflow (R-10017) FDA 510(k)3-in-1 Shaver 4.2mm (R-10008) FDA 510(k)3-in-1 Shaver 5.0mm (R-10014) FDA 510(k)Dynablator (R-10005) FDA 510(k)Standard Burr (R-10021) FDA 510(k)Standard Shaver 3.4mm (R-10012) FDA 510(k)Curved Standard Shaver 3.4mm (R-10024) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Tricera Arthroscopic System - Curved Standard Shaver 3.4mm (R-10024) by RELIGN Corporation — Class II — FDA_510K — listed in FDA 510(k) — 11 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 | K233493 | Class II | Active |
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Manufacturer
- Manufacturer
- RELIGN Corporation
Sources (1)
- FDA 510(k) K233493 24 fields · synced Jun 19, 2026