Ibi
FDA 510(k) K974440 · Gallini U.S., LLC
510(k) numberK974440
Submission
- Device name
- Ibi
- Applicant
- Gallini U.S., LLC
Richmond, VA, US - Received
- November 25, 1997
- Decision date
- January 30, 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
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 |
|---|---|---|
| K992499 | Gallini Biosystem Bone Marrow Aspiration/Biopsy NeedleKNW · Traditional | 08/12/1999SE |
| K990645 | Gallini Atra-Cut NeedleKNW · Traditional | 05/19/1999SE |
| K990716 | Gallini Bycut NeedleKNW · Traditional | 05/17/1999SE |
| K981301 | Speed-Cut Automatic Biopsy SystemKNW · Traditional | 07/08/1998SE |
| K980676 | Spigal NeedleKNW · Traditional | 05/21/1998SE |
| K980479 | Quick-Cut Automatic Biopsy SystemKNW · Traditional | 05/06/1998SE |
| K980248 | Acri R NeedleKNW · Traditional | 02/18/1998SE |
| K973152 | Gallini Abs DeviceKNW · Traditional | 01/09/1998SE |
| K972266 | Gallini Coaxial IntroducerKNW · Traditional | 07/29/1997SE |
Questions and answers
When was Ibi cleared by the FDA?
Ibi (K974440) received a 510(k) decision of Substantially Equivalent on January 30, 1998, 66 days after the submission was received.
What is the product code of K974440?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.