← Back to catalogue
Biopsy Needle
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref MMCI2203US510(k) K953880
Identity
- Trade Name
- Biopsy Needle EUDAMEDMaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- MaxiCell Biopsy Needle EUDAMEDMaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle FDA UDI
- Model / Reference
- MMCI2203US EUDAMEDFDA UDI
- Description
- MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle FDA UDI
Identifiers
- Catalog Number
- MMCI2203US FDA UDI
- Primary DI / UDI-DI
- 20886333002874 EUDAMED00886333002870 FDA UDI
- Basic UDI-DI
- B-20886333002874 EUDAMED
- 510(k) Number
- K980122 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Soft-tissue biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Diskectomy system, percutaneous, automatic
Biopsy Needle by Argon Medical Devices, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953880 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-20886333002874 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000002324
- FDA Applicant
- Biopsys Medical, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 22185f30-ee2b-4d90-a29b-c2f33d76e6ad 85 fields · synced Jun 18, 2026
- FDA UDI 17a7d0ba-1b5a-4c71-8776-39df5c970980 38 fields · synced May 30, 2026
- FDA 510(k) K953880 1 fields · synced May 19, 2026