Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1075](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1075) → KNW — Instrument, Biopsy # KNW · Instrument, Biopsy _Gastroenterology, Urology · 21 CFR 876.1075 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW ## Overview - **Product Code:** KNW - **Device Name:** Instrument, Biopsy - **Regulation:** [21 CFR 876.1075](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1075) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **3rd-party reviewable:** yes ## Identification A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Classification Rationale (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Recent Cleared Devices (20 of 360) Showing 20 most recent of 360 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260365](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K260365.md) | 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. | Mar 4, 2026 | SESE | | [K252795](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K252795.md) | 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 | Argon Medical Devices, Inc. | Feb 23, 2026 | SESE | | [K252681](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K252681.md) | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | Dec 12, 2025 | SESE | | [K252183](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K252183.md) | Resitu Slider 09 (RESL09) | Resitu Medical AB | Sep 24, 2025 | SESE | | [K243407](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K243407.md) | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | Jul 29, 2025 | SESE | | [K244018](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K244018.md) | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | Jul 22, 2025 | SESE | | [K243296](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K243296.md) | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | Jul 11, 2025 | SESE | | [K250032](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K250032.md) | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | Jul 10, 2025 | SESE | | [K243886](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K243886.md) | ExpressCore Biopsy Device | Inrad, Inc. | Apr 29, 2025 | SESE | | [K243945](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K243945.md) | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | Apr 24, 2025 | SESE | | [K242128](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K242128.md) | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | Feb 27, 2025 | SESE | | [K242322](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K242322.md) | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | Jan 24, 2025 | SESE | | [K241793](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K241793.md) | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | Jan 24, 2025 | SESE | | [K242228](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K242228.md) | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | Jan 10, 2025 | SESE | | [K243095](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K243095.md) | Mammotome AutoCore™ Single Insertion Core Biopsy System | Devicor Medical Products, Inc. | Oct 29, 2024 | SESE | | [K242029](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K242029.md) | TRAP EASY | H.S Hospital Service S.P.A | Oct 9, 2024 | SESE | | [K240664](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K240664.md) | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | Aug 9, 2024 | SESE | | [K233294](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K233294.md) | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | Itp Innovative Tomography Products GmbH | Jun 18, 2024 | SESE | | [K233031](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K233031.md) | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. | Jan 17, 2024 | SESE | | [K230646](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K230646.md) | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | Nov 29, 2023 | SESE | ## Top Applicants - Medical Device Technologies, Inc. — 15 clearances - C.R. Bard, Inc. — 11 clearances - Gallini U.S., LLC — 10 clearances - Manan Medical Products, Inc. — 10 clearances - Senorx, Inc. — 9 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com