FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
K Number: K252795
·
Decision Feb 23, 2026
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
20
Review Days
174
Basic Information
- Device Name
- ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
- K Number
- K252795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argon Medical Devices, Inc.
- Date Received
- September 2, 2025
- Decision Date
- February 23, 2026
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.
Promisemed VeriEcto Automatic Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EnCor EnCompass Breast Biopsy and Tissue Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Resitu Slider 09 (RESL09)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Forcyte Autograft Harvest Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Biopsy Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Argon Medical Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Feb 5, 2026 | Substantially Equivalent |
| K251318 | VariFuse Adjustable Infusion Catheter | Jan 20, 2026 | Substantially Equivalent |
| K253741 | VStick Vascular Access Set | Dec 15, 2025 | Substantially Equivalent |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | Sep 10, 2024 | Substantially Equivalent |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Aug 1, 2024 | Substantially Equivalent |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister | Mar 28, 2024 | Substantially Equivalent |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | Jan 19, 2024 | Substantially Equivalent |
| K233432 | 10F Sheath and Dilator Set | Dec 8, 2023 | Substantially Equivalent |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Sep 7, 2023 | Substantially Equivalent |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister | Apr 10, 2023 | Substantially Equivalent |