Identity
- Trade Name
- Reprocessed 3.5mm VAPR Side Effect Electrode FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
- Model / Reference
- 227301 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B3902273011 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 3.5mm VAPR Side Effect Electrode by Suretek Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
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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, Flexible Shaft — 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 |
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Manufacturer
- Manufacturer
- Suretek Medical
Sources (1)
- FDA UDI 4fc0dcc8-416a-4672-a09d-7c8294efca04 33 fields · synced May 29, 2026