Identity
- Trade Name
- Signature Series FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrosurgical Devices, cutting Loop FDA UDI
- Model / Reference
- M0068802390 FDA UDI
- Description
- Electrosurgical Devices, cutting Loop FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729890126 FDA UDI
- 510(k) Number
- K962593 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
- Catheter Gauge — 28 French FDA UDI
Category: Electrosurgical system
Signature Series by Prosurg, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrosurgical system.
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- Bovie — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K962593 also covers:
- Neoscope — Prosurg, Inc
- Prosurg — Prosurg, Inc
- Prosurg — Prosurg, Inc
- Prosurg — Prosurg, Inc
- Prosurg — Prosurg, Inc
- Prosurg — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, Inc
- Prosurg RF Electrodes — Prosurg, 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
- Prosurg, Inc
Sources (1)
- FDA UDI d31b304a-ad1b-439c-92f0-b928207f4b75 36 fields · synced Jun 8, 2026