510(k) K041544
- Device
- COOK SIDEARM CORE TISSUE BIOPSY DEVICE
- Applicant
- UROLOGICAL INC.
- 510(k) number
- K041544
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-07-22
- Date received
- 2004-06-09
- 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
- CINDY RUMPLE
- Address
- 1100 W. Morgan St. Spencer IN US 47460 47460
FDA Registration Numbers#
- 3005636544
- 3016050940
- 2027062
- 3007162296
- 3004749705
- 9611680
- 3033589330
- 3038356900
- 3014279513
- 2024311
- 3027260597
- 1423662
- 1450662
- 3004201275
- 9617616
- 3042940295
- 3006981798
- 3005496266
- 3004636440
- 1000112137
- 1820334
- 3010220595
- 3000126629
- 3030733800
- 1221485
- 9680001
- 1721686
- 3015806723
- 3010419931
- 2531475
- 3006063136
- 3015142721
- 3006849754
- 1720929
- 1048735
- 1721676
- 3010515547
- 3013440400
- 1000393132
- 3016844398
- 3007748770
- 1721983
- 3002808022
- 9611481
- 3044026004
- 3006950086
- 3004681601
- 2032098
- 3030447506
- 3018094310
- 1056553
- 3015980719
- 3012536737
- 3011642792
- 1649518
- 1226544
- 3005580113
- 3008496839
- 3009050824
- 1047843
- 3004105270
- 3012495575
- 3005216725
- 3007738736
- 3017636737
- 3010082909
- 3004962788
- 3009656988
- 1724474
- 3013188547
- 1018233
- 3004774118
- 1721504
- 3022977243
- 3012936513
- 3012447612
- 1644312
- 1222780
- 1220477
- 2246552
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 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| K242322 | Bone Marrow 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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