KNW — Instrument, Biopsy Class II
FDA Device Classification
Classification Details
- Product Code
- KNW
- Device Class
- Class II
- Regulation Number
- 876.1075
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K260365 | devicor medical products | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Ma | March 4, 2026 |
| K252795 | argon medical devices | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy De | February 23, 2026 |
| K252681 | bard peripheral vascular | EnCor EnCompass Breast Biopsy and Tissue Removal System | December 12, 2025 |
| K252183 | resitu medical | Resitu Slider 09 (RESL09) | September 24, 2025 |
| K243407 | forcyte medical | Forcyte Autograft Harvest Kit | July 29, 2025 |
| K244018 | zhejiang curaway medical technology co | Disposable Biopsy Needle | July 22, 2025 |
| K243296 | carbon (shenzhen) medical device co | Disposable Biopsy Needle | July 11, 2025 |
| K250032 | bard peripheral vascular | Marquee Disposable Core Biopsy Instrument and Instrument Kit | July 10, 2025 |
| K243886 | inrad | ExpressCore Biopsy Device | April 29, 2025 |
| K243945 | surgentec | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | April 24, 2025 |
| K242128 | xaga surgical | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsv | February 27, 2025 |
| K241793 | zhejiang curaway medical technology co | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposa | January 24, 2025 |
| K242322 | zhejiang curaway medical technology co | Bone Marrow Biopsy Needle | January 24, 2025 |
| K242228 | triopsy medical | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy | January 10, 2025 |
| K243095 | devicor medical products | Mammotome AutoCore Single Insertion Core Biopsy System | October 29, 2024 |
| K242029 | h.s hospital service | TRAP EASY | October 9, 2024 |
| K240664 | surgentec | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | August 9, 2024 |
| K233294 | itp innovative tomography products | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | June 18, 2024 |
| K233031 | canyon medical | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-a | January 17, 2024 |
| K230646 | uro-1 medical | SUREcore Prime Biopsy Instrument | November 29, 2023 |