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Kobold Fletcher- (Tandem +5 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K160610
by Kobold, Llc
Identifiers
- 510(k) Number
- K160610 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
- Models / Variants
- Tandem FDA 510(k)Ovoid Applicator Set FDA 510(k)Kobold Henschke-model Tandem FDA 510(k)Ovoid Applicator Set FDA 510(k)Kobold Vaginal Cylinder Applicator Set FDA 510(k)Kobold Miami Cylinder Applicator Set FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Kobold Fletcher- (Tandem +5 more) by Kobold, Llc — Class II — FDA_510K — listed in FDA 510(k) — 6 models — 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 | K160610 | Class II | Active |
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Manufacturer
- Manufacturer
- Kobold, Llc
Sources (1)
- FDA 510(k) K160610 24 fields · synced Jun 18, 2026