Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable Biopsy Forceps Serrated Cup, Reusar
FDA 510(k) K974312 · Telemed Systems, Inc.
510(k) numberK974312
Submission
- Device name
- Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable Biopsy Forceps Serrated Cup, Reusar
- Applicant
- Telemed Systems, Inc.
Marlborough, MA, US - Received
- November 17, 1997
- Decision date
- January 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K020379 | PPD Balloon Dilatation CatheterKNT · Special | 05/06/2002SE |
| K013737 | Modification to: 3-LUMEN Duralon Occlusion BalloonFGE · Special | 03/01/2002SE |
| K010412 | Flexible Endoscopic ScissorsOCZ · Traditional | 04/02/2001SE |
| K992402 | 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip…KNS · Traditional | 12/22/1999SE |
| K992390 | Hot Biopsy Forceps Feenestrated 230 CM Oval Cup, Hot Biopsy Forceps Serrated 160 CM Oval…KGE · Traditional | 12/22/1999SE |
| K974300 | Telemed Systems Retrieval BasketOCZ · Traditional | 12/19/1997SE |
| K901435 | Gastrointestinal Cytology BrushFDX · Traditional | 07/16/1990SE |
| K901427 | Biliary Stone Retrieval and Occlusion BalloonFGE · Traditional | 06/22/1990SE |
| K901433 | Sure-Flex Anastomotic Balloon DilatorFGE · Traditional | 06/21/1990SE |
| K901432 | Biliary Balloon DilatorFGE · Traditional | 06/21/1990SE |
Questions and answers
When was Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable Biopsy Forceps Serrated Cup, Reusar cleared by the FDA?
Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/Needle, Reusable Biopsy Forceps Serrated Cup, Reusar (K974312) received a 510(k) decision of Substantially Equivalent on January 21, 1998, 65 days after the submission was received.
What is the product code of K974312?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.