Trap Easy
FDA 510(k) K242029 · H.S Hospital Service S.P.A
510(k) numberK242029
Submission
- Device name
- Trap Easy
- Applicant
- H.S Hospital Service S.P.A
Rome, IT - Received
- July 11, 2024
- Decision date
- October 9, 2024
- 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
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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 |
|---|---|---|
| K232072 | Amica-Gen AGN-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GGEI · Traditional | 02/09/2024SE |
| K182605 | HS AMICA devices familyGEI · Traditional | 10/28/2019SE |
| K150112 | HS Amica Devices FamilyGEI · Traditional | 09/10/2015SE |
| K083157 | HS AmicaNEY · Traditional | 09/29/2009SE |
| K033616 | Trapmatic System SetKNW · Traditional | 03/01/2004SE |
Questions and answers
When was Trap Easy cleared by the FDA?
Trap Easy (K242029) received a 510(k) decision of Substantially Equivalent on October 9, 2024, 90 days after the submission was received.
What is the product code of K242029?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.