Modification to En-Bloc Biopsy System
FDA 510(k) K033427 · Neothermia Corp.
510(k) numberK033427
Submission
- Device name
- Modification to En-Bloc Biopsy System
- Applicant
- Neothermia Corp.
Natick, MA, US - Received
- October 28, 2003
- Decision date
- November 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K052246 | Modification to En-Bloc Biopsy SystemGEI · Traditional | 08/22/2005SE |
| K050737 | Neothermia En-Bloc Biopsy SystemGEI · Special | 03/31/2005SE |
| K042170 | En-Bloc Biopsy System MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-1…GEI · Special | 09/07/2004SE |
| K041347 | Modification to En-Bloc Biopsy SystemGEI · Special | 06/04/2004SE |
| K023413 | Modification to Neothermia's En-Bloc Biopsy SystemGEI · Special | 11/08/2002SE |
| K022296 | Modification to En-Bloc Biopsy SystemGEI · Special | 07/30/2002SE |
| K021577 | Modification to En-Bloc Biopsy SystemGEI · Special | 05/29/2002SE |
| K020031 | En-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302GEI · Traditional | 03/27/2002SE |
| K003190 | En Bloc Biopsy SystemGEI · Traditional | 06/11/2001SE |
Questions and answers
When was Modification to En-Bloc Biopsy System cleared by the FDA?
Modification to En-Bloc Biopsy System (K033427) received a 510(k) decision of Substantially Equivalent on November 10, 2003, 13 days after the submission was received.
What is the product code of K033427?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.