510(k) K862562
- Device
- PUNCH BIOPSY KIT
- Applicant
- CLINIPAD CORP.
- 510(k) number
- K862562
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-07
- Date received
- 1986-07-03
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SIDNEY FINKELSTEIN
- Address
- 66 High St. P.O. Box 387 Guilford CT US 06437 06437
FDA Registration Numbers#
- 3009656988
- 3007185216
- 3015225571
- 3010966701
- 3002808022
- 3005216725
- 3014032451
- 3013557562
- 3007162296
- 1061124
- 1820334
- 3004122598
- 3012495575
- 3009337401
- 3012494290
- 1056553
- 2649614
- 3015077548
- 1319639
- 3013727803
- 9611680
- 3027269340
- 3007014520
- 2648623
- 1226544
- 3006063136
- 1220246
- 3015136750
- 3004774118
- 1061927
- 1721686
- 1417485
- 1220477
- 2528981
- 3010419931
- 9680340
- 2024311
- 3004024955
- 1018233
- 2648666
- 1058584
- 3044399745
- 1319660
- 1054811
- 3015967359
- 3015231789
- 1222168
- 3011137372
- 3044026004
- 2032098
- 1423507
- 1835568
- 2433012
- 1423537
- 3006950086
- 3033858858
- 3013875526
- 3033589330
- 2133810
- 3010273872
- 8010312
- 3004598644
- 3021023752
- 2134812
- 1644312
- 1419411
- 3012470322
- 3006849754
- 9680904
- 3015142721
- 3022977243
- 3003500271
- 3004962788
- 1056129
- 1720929
- 1000393132
- 1825146
- 3014279513
- 1000484830
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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