510(k) K252795
- Device
- 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
- Applicant
- Argon Medical Devices, Inc.
- 510(k) number
- K252795
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-23
- Date received
- 2025-09-02
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Jacquelyn Huyghue
- Address
- 1445 Flat Creek Rd. Athens TX US 75751 75751
FDA Registration Numbers
- 1423662
- 1450662
- 3006788678
- 1825146
- 3038356900
- 3007200016
- 3022977243
- 1423507
- 1221485
- 3015980719
- 9617592
- 1061124
- 2027062
- 3001592626
- 1222168
- 1037885
- 3012536737
- 3013188547
- 3009077524
- 3007513241
- 3004122598
- 3007137598
- 2320767
- 1644312
- 3018507299
- 2032098
- 3004598644
- 3016688836
- 3005636544
- 3006063136
- 3015142721
- 3015806723
- 3003500271
- 2649614
- 3030447506
- 2648727
- 3011504993
- 3013557562
- 2246552
- 1123169
- 2133772
- 3012936513
- 1319660
- 1423537
- 1721676
- 3015219237
- 3010515547
- 1820334
- 3007664053
- 3033589330
- 3006950086
- 9611680
- 3004749705
- 3008992312
- 3017210488
- 3017636737
- 3007648417
- 3008773560
- 3012495575
- 9611612
- 1018233
- 1417485
- 3009423112
- 3004636440
- 3030733800
- 3013875526
- 3010331645
- 1625425
- 3027269340
- 3014032451
- 3030626857
- 3010097171
- 1835568
- 3015231789
- 3002808022
- 3014279513
- 1000484830
- 1056129
- 1649518
Source Documents
Other 510(k) Records For Product Code KNW
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| K260365 | 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 | Devicor Medical Products, Inc. | 2026-03-04 |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | 2025-02-27 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | 2025-01-10 |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | 2024-10-29 |