Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
FDA 510(k) K210946 · Promisemed Hangzhou Meditech Co., Ltd.
510(k) numberK210946
Submission
- Device name
- Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- March 30, 2021
- Decision date
- August 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | 08/25/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | 05/12/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | 05/01/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | 04/16/2026SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | 06/04/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | 10/04/2024SE |
Questions and answers
When was Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles cleared by the FDA?
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (K210946) received a 510(k) decision of Substantially Equivalent on August 12, 2021, 135 days after the submission was received.
What is the product code of K210946?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.