Meadox(R) Surgimed(R) Biopsy Gun II
FDA 510(k) K911635 · Meadox Surgimed, Inc.
510(k) numberK911635
Submission
- Device name
- Meadox(R) Surgimed(R) Biopsy Gun II
- Applicant
- Meadox Surgimed, Inc.
Oakland, NJ, US - Received
- April 11, 1991
- Decision date
- June 20, 1991
- 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 |
|---|---|---|
| K944143 | MS Classique Balloon CatheterFGE · Traditional | 03/13/1995SE |
| K945061 | Noprofile Olbert Catheter SystemKOD · Traditional | 03/09/1995SE |
| K942382 | MS Amplatz Extra Stiff Guide WireDQX · Traditional | 08/22/1994SE |
| K930201 | Acecut Sutomatic Biopsy SystemKNW · Traditional | 06/09/1993SE |
| K905181 | No Profile Olbert Catheter System for UrologyEZN · Traditional | 03/06/1991SE |
| K904582 | Quickwire - Hydrophilic Coated GuidewireDQX · Traditional | 02/25/1991SE |
| K904983 | Meadox(R) Surgimed Olbert Cath Syst for UrologyEZN · Traditional | 01/30/1991SE |
| K902461 | Meadox Surgimed Biopsy Gun and NeedleKNW · Traditional | 07/16/1990SE |
| K890926 | Surecut BMB Bone Marrow Biopsy/Aspiration NeedleFMI · Traditional | 06/20/1989SE |
| K863218 | Cytostatic Filtration SetLFK · Traditional | 02/12/1987SE |
Questions and answers
When was Meadox(R) Surgimed(R) Biopsy Gun II cleared by the FDA?
Meadox(R) Surgimed(R) Biopsy Gun II (K911635) received a 510(k) decision of Substantially Equivalent on June 20, 1991, 70 days after the submission was received.
What is the product code of K911635?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.