Identity
- Trade Name
- Radiofrequency (RF) Needle FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
- Device Name
- 18G x 15cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Pink Cap FDA UDI
- Model / Reference
- S181510CVSQ1PEL FDA UDI
- Description
- 18G x 15cm x 10mm Active Tip, Sharp RF Needle, Echogenic Tip, Lubrication, Curved, Pink Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- M661S181510CVSQ1 FDA UDI
- 510(k) Number
- K032196 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4725 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
Category: Percutaneous radio-frequency ablation probe cannula, single-use
Radiofrequency (RF) Needle by Spectra Medical Devices, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe cannula, single-use.
- OWL — Diros Technology, Inc. · Class II
- OWL — Diros Technology, Inc. · Class II
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- OWL — Diros Technology, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- RadiOpaque Radiofrequency Cannula — Avanos Medical, Inc. · Class II
- LCCS — Lccs Products Limited · Class II
- OWL — Diros Technology, Inc. · Class II
Cleared under the same submission
K032196 also covers:
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
- Radiofrequency (RF) Needle — Spectra Medical Devices, LLC
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
- Spectra Medical Devices, LLC
Sources (1)
- FDA UDI e14c63ec-c699-48a1-bac4-55e97be0cdd6 34 fields · synced Jun 9, 2026