510(k) K190378
- Device
- Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge With 10 Mm Helix
- Applicant
- Bioncise NV
- 510(k) number
- K190378
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-24
- Date received
- 2019-02-19
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jaak Janssens
- Address
- Bodemstraat 16 Wellen BE 3500 3500
FDA Registration Numbers#
- 1222780
- 1722746
- 3003500271
- 3015173212
- 1221485
- 1423537
- 2024311
- 9611481
- 3008773560
- 2029275
- 3007200016
- 3004201275
- 1000484830
- 1056553
- 2528981
- 9680340
- 3006981798
- 3016844398
- 3027269340
- 1211566
- 3011642792
- 1423662
- 3010966701
- 3011088743
- 3015974593
- 2133772
- 3038611181
- 3027260597
- 3005636544
- 1625425
- 2320767
- 2649614
- 3014408997
- 2648623
- 3006788678
- 1625685
- 3004636440
- 3014004349
- 3004598644
- 1047843
- 3018094310
- 2433012
- 3010331645
- 1048735
- 3016688836
- 1319639
- 3008492462
- 1018233
- 1835568
- 3004962788
- 3015980719
- 3015924373
- 3004749705
- 3015136750
- 9680904
- 3013041594
- 1423507
- 3010097171
- 2183613
- 3012470322
- 3007648417
- 1828424
- 3001592626
- 3017636737
- 3005216725
- 3007014520
- 1223821
- 1721686
- 1219930
- 3013188547
- 3004024955
- 1220477
- 3010220595
- 3015231789
- 3005580113
- 3007137598
- 3013875526
- 1222168
- 3010273872
Source Documents#
Other 510(k) Records For Product Code KNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | 2025-02-27 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | 2025-01-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases