Chrysalis Intelligence · Product Codes · KNW

KNW · Instrument, Biopsy

Gastroenterology, Urology · 56 clearances · 36 unique sponsors

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Device class
Class II
Regulation 876.1075
Total clearances
56
2020-02-27 → 2026-08-28
Last 12 months
8
Unique sponsors
36
Classification details
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
Zhejiang Curaway Medical Technology Co., Ltd. 4 1 2026-08-28
Devicor Medical Products, Inc. 3 1 2026-03-04
Promisemed Hangzhou Meditech Co., Ltd. 3 1 2026-05-12
Argon Medical Devices, Inc. 2 1 2026-02-23
Suzhou Leapmed Healthcare Corporation 2 0 2022-07-06
Medax Srl Unipersonale 2 0 2020-04-02
SurGenTec, LLC 2 0 2025-04-24
Senorx, Inc. 2 0 2023-10-27
Uro-1, Inc. 2 0 2022-12-02
Canyon Medical, Inc. 2 0 2024-01-17
Itp Innovative Tomography Products GmbH 2 0 2024-06-18
Ranfac Corporation 2 0 2023-02-21
Transmed7, LLC 1 0 2020-08-07
Hologic, Inc. 1 1 2026-08-12
Arthrex, Inc. 1 0 2021-11-19
Inrad, Inc. 1 0 2025-04-29
Avitus Orthopaedics, Inc. 1 0 2021-03-31
Uramix, Inc. 1 0 2021-09-17
Forcyte Medical, LLC 1 0 2025-07-29
Neodynamics AB 1 0 2022-09-08
Merit Medical Systems, Inc. 1 0 2020-08-28
Medimetrix, LLC 1 1 2026-08-04
Laurane Medical Sas 1 0 2023-06-16
Teesuvac Aps 1 0 2022-02-02
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
2026-08-28 K260517 Zhejiang Curaway Medical Technology Co., Ltd. Automatic Core Biopsy Instrument
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
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence