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Disposable Monopolar Laparoscopic Shafts and Reusable Handles
FDA 510(k)Class II (US FDA 510(k))
510(k) K210569
by Dannik LLC
Identifiers
- 510(k) Number
- K210569 FDA 510(k)
- FDA Product Code
- GEI 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)
Disposable Monopolar Laparoscopic Shafts and Reusable Handles by Dannik LLC — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K210569 | Class II | Active |
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Manufacturer
- Manufacturer
- Dannik LLC
- FDA Applicant
- Dannik, LLC
Sources (1)
- FDA 510(k) K210569 24 fields · synced Jun 18, 2026