Identity
- Trade Name
- Reprocessed Carpal Tunnel Release Blade FDA UDI
- Generic Name
- Hand ligament surgical release instrument FDA UDI
- Model / Reference
- 81010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B390810101 FDA UDI
- 510(k) Number
- K052692 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Hand ligament surgical release instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Hand ligament surgical release instrument
Reprocessed Carpal Tunnel Release Blade by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand ligament surgical release instrument.
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 3.5mm 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
- 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suretek Medical
Sources (1)
- FDA UDI ee3c5e3d-d409-4079-8740-d9417caef8c9 33 fields · synced May 31, 2026