Identity
- Trade Name
- Reprocessed Procise XP Wand w/ Saline Line, Cable FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
- Model / Reference
- EICA8872-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B390EICA8872011 FDA UDI
- 510(k) Number
- K052692 FDA UDI
- FDA Product Code
- NUJ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed 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
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Reprocessed Procise XP Wand w/ Saline Line, Cable by Suretek Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052692 also covers:
- Reprocessed 2.3mm VAPR Side Effect Electrode — SURETEK MEDICAL
- Reprocessed 2.3mm VAPR Side Effect Electrode, Short — SURETEK MEDICAL
- Reprocessed 2.3mm VAPR Wedge Electrode — SURETEK MEDICAL
- Reprocessed 2.3mm VAPR Wedge Electrode — SURETEK MEDICAL
- Reprocessed 2.3mm VAPR Wedge Electrode, Short, w/ Cable — SURETEK MEDICAL
- Reprocessed 2mm Micro Ablator, 60 Deg — SURETEK MEDICAL
- Reprocessed 2mm Micro Ablator, 60 Deg, w/Suction, Monopolar — SURETEK MEDICAL
- Reprocessed 3.3mm Premier 90 Electrode w/Integrated Cable — SURETEK MEDICAL
- Reprocessed 3.5mm Side Effect Electrode, 21 Deg — SURETEK MEDICAL
- Reprocessed 3.5mm VAPR Hook Electrode — SURETEK MEDICAL
- Reprocessed 3.5mm VAPR Side Effect Electrode — SURETEK MEDICAL
- Reprocessed 3.5mm VAPR Side Effect Electrode — SURETEK MEDICAL
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suretek Medical
Sources (1)
- FDA UDI ab8b37c0-a38b-4306-8de3-e692e99918ad 33 fields · synced Jun 8, 2026