Identity
- Trade Name
- StarBurst FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- RITA StarBurst XL Electrosurgical Device FDA UDI
- Model / Reference
- 700-103903 FDA UDI
- Description
- RITA StarBurst XL Electrosurgical Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- H7877001039031 FDA UDI
- 510(k) Number
- K992693 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
StarBurst by Navilyst Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar.
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Cleared under the same submission
K992693 also covers:
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
- StarBurst — NAVILYST MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 713b8886-af28-4baa-bead-634613e1cebb 36 fields · synced May 30, 2026