510(k) K962077
- Device
- BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K962077
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-30
- Date received
- 1996-05-28
- 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 VIERLING
- Address
- 129 Concord Rd. Bldg. #3 Billerica MA US 01821 01821
FDA Registration Numbers#
- 1825146
- 3030447506
- 1419411
- 3030626857
- 2649614
- 1018233
- 9680794
- 1835568
- 3018507299
- 3004105270
- 3015967359
- 1526711
- 3005580113
- 1625425
- 3014004349
- 3004681601
- 1061124
- 3000126629
- 1219114
- 3010041511
- 3027269340
- 2320767
- 3015142721
- 2433012
- 3001592626
- 3015924373
- 3022977243
- 3010339638
- 3015173212
- 3012536737
- 3004111573
- 1226544
- 1054811
- 2030624
- 3007513241
- 1724474
- 3033589330
- 9617616
- 1056553
- 3016844398
- 3010220595
- 1417485
- 2648666
- 1721983
- 3005636544
- 3004636440
- 3004962788
- 3009050824
- 3012495575
- 3033858858
- 3010966701
- 3008773560
- 3007648417
- 3042940295
- 9611680
- 3011245468
- 1450662
- 3006330030
- 1226146
- 3013440400
- 3014408997
- 9680001
- 3010097171
- 3021023752
- 3015309643
- 3004598644
- 1319639
- 3016688836
- 2024311
- 3010419931
- 1037885
- 9611612
- 1424263
- 3038611181
- 3016678045
- 3010273872
- 1820334
- 1219930
- 3006063136
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#
summary
FDA Review#
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