Chrysalis Intelligence · Product Codes · KNW

KNW · Instrument, Biopsy

Gastroenterology, Urology · 55 clearances · 36 unique sponsors

Device class
Class II
Regulation 876.1075
Total clearances
55
2020-02-27 → 2026-08-14
Last 12 months
8
Unique sponsors
36
Medical specialty
Gastroenterology, Urology
Review panel
SU
Regulation number
876.1075
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Bard Peripheral Vascular, Inc. 5 2 2026-08-14
Devicor Medical Products, Inc. 3 1 2026-03-04
Promisemed Hangzhou Meditech Co., Ltd. 3 1 2026-05-12
Zhejiang Curaway Medical Technology Co., Ltd. 3 0 2025-07-22
Suzhou Leapmed Healthcare Corporation 2 0 2022-07-06
Medax Srl Unipersonale 2 0 2020-04-02
Itp Innovative Tomography Products GmbH 2 0 2024-06-18
SurGenTec, LLC 2 0 2025-04-24
Uro-1, Inc. 2 0 2022-12-02
Senorx, Inc. 2 0 2023-10-27
Canyon Medical, Inc. 2 0 2024-01-17
Argon Medical Devices, Inc. 2 1 2026-02-23
Ranfac Corporation 2 0 2023-02-21
H.S Hospital Service S.P.A 1 0 2024-10-09
Hologic, Inc. 1 1 2026-08-12
Laurane Medical Sas 1 0 2023-06-16
Transmed7, LLC 1 0 2020-08-07
Apriomed AB 1 0 2020-02-27
Merit Medical Systems, Inc. 1 0 2020-08-28
Neodynamics AB 1 0 2022-09-08
Forcyte Medical, LLC 1 0 2025-07-29
Uramix, Inc. 1 0 2021-09-17
Medimetrix, LLC 1 1 2026-08-04
Teesuvac Aps 1 0 2022-02-02
Carbon (Shenzhen) Medical Device Co., Ltd. 1 0 2025-07-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
43239 CPT Medium Upper endoscopy with biopsy, single or multiple specimens
45398 CPT Medium Colonoscopy with biopsy, single or multiple specimens
A4204 HCPCS Medium Biopsy forceps for flexible endoscope
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-14 K262571 Bard Peripheral Vascular, Inc. EnCor EnCompass™ Breast Biopsy and Tissue Removal System
2026-08-12 K262792 Hologic, Inc. Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
2026-08-04 K260572 Medimetrix, LLC Marrow Marxman
2026-05-12 K261196 Promisemed Hangzhou Meditech Co., Ltd. Promisemed VeriEcto Automatic Biopsy Needles
2026-03-04 K260365 Devicor Medical Products, Inc. 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
2026-02-23 K252795 Argon Medical Devices, Inc. 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
2025-12-12 K252681 Bard Peripheral Vascular, Inc. EnCor EnCompass™ Breast Biopsy and Tissue Removal System
2025-09-24 K252183 Resitu Medical AB Resitu Slider 09 (RESL09)
2025-07-29 K243407 Forcyte Medical, LLC Forcyte Autograft Harvest Kit
2025-07-22 K244018 Zhejiang Curaway Medical Technology Co., Ltd. Disposable Biopsy Needle
2025-07-11 K243296 Carbon (Shenzhen) Medical Device Co., Ltd. Disposable Biopsy Needle
2025-07-10 K250032 Bard Peripheral Vascular, Inc. Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
2025-04-29 K243886 Inrad, Inc. ExpressCore Biopsy Device
2025-04-24 K243945 SurGenTec, LLC ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
2025-02-27 K242128 Xaga Surgical Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
2025-01-24 K242322 Zhejiang Curaway Medical Technology Co., Ltd. Bone Marrow Biopsy Needle
2025-01-24 K241793 Zhejiang Curaway Medical Technology Co., Ltd. Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
2025-01-10 K242228 Triopsy Medical, Inc. Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
2024-10-29 K243095 Devicor Medical Products, Inc. Mammotome AutoCore™ Single Insertion Core Biopsy System
2024-10-09 K242029 H.S Hospital Service S.P.A TRAP EASY
2024-08-09 K240664 SurGenTec, LLC ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
2024-06-18 K233294 Itp Innovative Tomography Products GmbH Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
2024-01-17 K233031 Canyon Medical, Inc. M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
2023-11-29 K230646 Uro-1 Medical, Inc. SUREcore Prime Biopsy Instrument
2023-10-27 K233220 Senorx, Inc. EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)