Identity
- Trade Name
- ENCOR® FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- ENCOR® Probe Stereotactic/Ultrasound 7GV Upright FDA UDI
- Model / Reference
- ECP017GV FDA UDI
- Description
- ENCOR® Probe Stereotactic/Ultrasound 7GV Upright FDA UDI
Identifiers
- Catalog Number
- ECP017GV FDA UDI
- Primary DI / UDI-DI
- 00801741086298 FDA UDI
- 510(k) Number
- K051158 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
- Needle Gauge — 7 Gauge FDA UDI
Category: Soft-tissue biopsy procedure kit, non-medicated
Encor® by Senorx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051158 also covers:
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
- Senorx, Inc.
Sources (1)
- FDA UDI 8dddff75-7ab4-4420-aae1-2f6f66e969cd 37 fields · synced Jun 8, 2026