KNW — Instrument, Biopsy Class II
FDA product code KNW covers "Instrument, Biopsy", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261196 | promisemed hangzhou meditech co | Promisemed VeriEcto Automatic Biopsy Needles | May 12, 2026 |
| 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 |
| K242322 | zhejiang curaway medical technology co | Bone Marrow Biopsy Needle | January 24, 2025 |
| K241793 | zhejiang curaway medical technology co | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposa | 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 |