Manan Menghini Needle
FDA 510(k) K851836 · Manan Manufacturing Co., Inc.
510(k) numberK851836
Submission
- Device name
- Manan Menghini Needle
- Applicant
- Manan Manufacturing Co., Inc.
Skokie, IL, US - Received
- April 28, 1985
- Decision date
- June 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K873208 | Manan Turner Style NeedleKNW · Traditional | 08/25/1987SE |
| K864405 | Manan Contrast Media Administration SetFPA · Traditional | 12/18/1986SE |
| K863848 | Manan Brest Tumor Localization NeedleGAA · Traditional | 10/14/1986SE |
| K852501 | Myelogram Procedure Tray · Traditional | 07/11/1985SESD |
| K852018 | Arthrogram Tray for Double & Single Contrast Arthr · Traditional | 07/11/1985SESD |
| K851834 | Manan Gwi Guide Wire IntroducerDWS · Traditional | 07/11/1985SE |
| K851833 | Manan Seldinger NeedleDWS · Traditional | 07/11/1985SE |
| K851832 | Naman Potts Cournand NeedleDWS · Traditional | 07/11/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | 06/27/1985SE |
| K852427 | Manan Spinal NeedleGAA · Traditional | 06/27/1985SE |
Questions and answers
When was Manan Menghini Needle cleared by the FDA?
Manan Menghini Needle (K851836) received a 510(k) decision of Substantially Equivalent on June 21, 1985, 54 days after the submission was received.
What is the product code of K851836?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.