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AprioCore plus 16G, 13.5 cm
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref ACP16-135-10
by AprioMed AB
Identity
- Trade Name
- AprioCore plus 16G, 13.5 cm EUDAMEDAprioCore plus FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- AprioCore EUDAMEDAprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle. FDA UDI
- Model / Reference
- ACP16-135-10 EUDAMEDFDA UDI
- Description
- AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle. FDA UDI
Identifiers
- Catalog Number
- ACP16-135-10 FDA UDI
- Primary DI / UDI-DI
- 07350031350128 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500313510KE EUDAMED
- 510(k) Number
- K193268 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 13.5 Centimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
AprioCore plus 16G, 13.5 cm by Apriomed AB — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193268 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 73500313510KE | Class IIa | Active |
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Manufacturer
- Manufacturer
- AprioMed AB
- EUDAMED SRN
- SE-MF-000001013
Sources (3)
- EUDAMED c2784bbc-9c3a-4894-b02a-ab6211c7e1f3 61 fields · synced Jun 20, 2026
- FDA UDI 470ad5e4-4732-42f3-9652-5fd47feca66e 37 fields · synced May 30, 2026
- FDA 510(k) K193268 1 fields · synced May 18, 2026