510(k) K974158
- Device
- ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
- Applicant
- ORTHO DEVELOPMENT CORP.
- 510(k) number
- K974158
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-09
- Date received
- 1997-11-03
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL FRASIER
- Address
- 106 W. 12200 S. Draper UT US 84020 84020
FDA Registration Numbers#
- 3014032451
- 3030446844
- 3018094310
- 3042940295
- 3008044552
- 3004122598
- 3006788678
- 3007648417
- 1226544
- 9617616
- 3021023752
- 1835568
- 3007748770
- 1000484830
- 3002806603
- 3019807891
- 2531475
- 3030626857
- 3022977243
- 9617592
- 3007162296
- 3004962788
- 3007137598
- 1061124
- 3006981798
- 3011504993
- 3044399745
- 3007664053
- 1221485
- 2134812
- 1722746
- 3009050824
- 3015980719
- 3004111573
- 3011245468
- 3015806723
- 3011137372
- 3033589330
- 2953359
- 3044026004
- 9611612
- 2246552
- 3006786907
- 3015924373
- 1625425
- 9680794
- 3011088743
- 3017448139
- 9680904
- 1921846
- 3003500271
- 1056129
- 2648666
- 3016050940
- 3007738736
- 2020394
- 3016678045
- 3006330030
- 3030733800
- 1820334
- 3038356900
- 1056553
- 3015225571
- 3015142721
- 1058584
- 3004598644
- 3000126629
- 3004636440
- 3010273872
- 3009609358
- 3018507299
- 3033858858
- 1528319
- 2133772
- 3015136750
- 2024311
- 3014408997
- 1222168
- 3010082909
- 3015173212
Source Documents#
Other 510(k) Records For Product Code KNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | 2026-08-28 |
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2026-08-14 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026-08-12 |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. | 2026-03-04 |
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. | 2026-02-23 |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 |
Legacy Summary#
summary
FDA Review#
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