Identity
- Trade Name
- SuperCore Advantage™ FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- SuperCore Advantage™ Semi-Automatic Biopsy Instrument 18ga x 10cm (Use with Optional Co-Axial Cannula Bundle: 17ga x 5.6cm & Cannula Bundle Catalog Number: MCXS1810BX) FDA UDI
- Model / Reference
- 801118100 FDA UDI
- Description
- SuperCore Advantage™ Semi-Automatic Biopsy Instrument 18ga x 10cm (Use with Optional Co-Axial Cannula Bundle: 17ga x 5.6cm & Cannula Bundle Catalog Number: MCXS1810BX) FDA UDI
Identifiers
- Catalog Number
- 801118100 FDA UDI
- Primary DI / UDI-DI
- 00886333226061 FDA UDI
- 510(k) Number
- K213232 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- End-cut biopsy gun handpiece/needle 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
Yes
FDA UDI
Category: End-cut biopsy gun handpiece/needle
SuperCore Advantage™ by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun handpiece/needle.
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- SemiCut Coax. — M.D.L. S.R.L. · Class II
- SemiCut — M.D.L. S.R.L. · Class II
- Themy — M.D.L. S.R.L. · Class II
- SemiCut Coax. — M.D.L. S.R.L. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K213232 also covers:
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
- SuperCore Advantage™ — Argon Medical Devices, Inc.
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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 75c470f5-62f2-4b3d-b8f4-0a12631ff8c0 38 fields · synced Jun 9, 2026