Chiba Sono
FDA 510(k) K113209 · Pajunk GmbH
510(k) numberK113209
Submission
- Device name
- Chiba Sono
- Applicant
- Pajunk GmbH
Geisingen, DE - Received
- October 31, 2011
- Decision date
- November 21, 2011
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K113207 | Sono Tap, Tuohy SonoBSP · Traditional | 02/29/2012SE |
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| K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetCAZ · Special | 01/12/2006SE |
| K053282 | Adaptable Monopolar Electrodes with Ceramic TipGEI · Special | 12/13/2005SE |
| K043130 | Modification to Pajunk Stimulong Plus Catheter SetsCAZ · Special | 12/21/2004SE |
| K042979 | Modification to: Plexalong SetsBSP · Special | 12/21/2004SE |
| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesBSP · Traditional | 09/07/2004SE |
| K033018 | Stimulong Plus Catheter Set Model, VariousCAZ · Traditional | 05/05/2004SE |
| K033249 | Pajunk Modular Handle InstrumentsGCJ · Traditional | 03/05/2004SE |
| K023218 | Modification to Plexolong SetsBSP · Special | 03/24/2003SE |
Questions and answers
When was Chiba Sono cleared by the FDA?
Chiba Sono (K113209) received a 510(k) decision of Substantially Equivalent on November 21, 2011, 21 days after the submission was received.
What is the product code of K113209?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.