Ranfac Aspiration Needle with Adjustable Guide
FDA 510(k) K140991 · Ranfac, Corp.
510(k) numberK140991
Submission
- Device name
- Ranfac Aspiration Needle with Adjustable Guide
- Applicant
- Ranfac, Corp.
Avon, MA, US - Received
- April 17, 2014
- Decision date
- September 11, 2014
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)KNW · Special | 02/21/2023SE |
| K202287 | Ran-Flex-B Bone Marrow Aspiration NeedleKNW · Traditional | 09/18/2020SE |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW · Special | 06/12/2019SE |
| K183146 | Ranfac Cartilage Biopsy NeedleKNW · Traditional | 04/25/2019SE |
| K162932 | Ranfac Fat Aspiration CannulaMUU · Traditional | 01/19/2017SE |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration…MUU · Traditional | 10/19/2015SE |
| K150563 | Marrow Cellution Bone Marrow Aspiration NeedleKNW · Traditional | 05/22/2015SE |
| K131157 | Ranfac Bone Marrow Aspiration NeedleKNW · Traditional | 10/22/2013SE |
| K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleKNW · Traditional | 05/23/2003SE |
| K012224 | Single Action Biopsy Needle, Model RCBS: XX Gauge, XX Length, XX ThrowKNW · Traditional | 08/22/2001SE |
Questions and answers
When was Ranfac Aspiration Needle with Adjustable Guide cleared by the FDA?
Ranfac Aspiration Needle with Adjustable Guide (K140991) received a 510(k) decision of Substantially Equivalent on September 11, 2014, 147 days after the submission was received.
What is the product code of K140991?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.