Identity
- Trade Name
- ENCOR® FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 10G FDA UDI
- Model / Reference
- ECMRINTLOC FDA UDI
- Description
- ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 10G FDA UDI
Identifiers
- Catalog Number
- ECMRINTLOC FDA UDI
- Primary DI / UDI-DI
- 00801741086229 FDA UDI
- 510(k) Number
- K161805 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
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
K161805 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 c0d55877-555c-4be0-af53-52c9f156cdca 37 fields · synced May 30, 2026