FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
K Number: K233031
·
Decision Jan 17, 2024
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
5
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
- K Number
- K233031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canyon Medical, Inc.
- Date Received
- September 25, 2023
- Decision Date
- January 17, 2024
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.
Promisemed VeriEcto Automatic Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EnCor EnCompass Breast Biopsy and Tissue Removal System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Resitu Slider 09 (RESL09)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Forcyte Autograft Harvest Kit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Canyon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250209 | Polyvinyl Alcohol Embolic Microspheres | Sep 23, 2025 | Substantially Equivalent |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Sep 26, 2024 | Substantially Equivalent |
| K241825 | Microwave Ablation Antennas | Sep 20, 2024 | Substantially Equivalent |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle | Apr 3, 2023 | Substantially Equivalent |