510(k) K960065
- Device
- TEMNO DOUBLE SHOT BIOPSY NEEDLE
- Applicant
- BAUER MEDICAL, INC.
- 510(k) number
- K960065
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-05
- Date received
- 1996-01-05
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT LAMB
- Address
- 13191 56th Ct. Suite 106 Clearwater FL US 34620 34620
FDA Registration Numbers#
- 3015231789
- 3004122598
- 3002808022
- 1222780
- 3006063136
- 3004681601
- 1319660
- 1048735
- 3021023752
- 2648666
- 3015309643
- 1047843
- 3006849754
- 3001592626
- 3013462478
- 3007513241
- 3012936513
- 9611680
- 3012495575
- 1226544
- 3011642792
- 1721504
- 3009656988
- 2648623
- 3044026004
- 3006330030
- 1649518
- 1625425
- 3027260597
- 1319639
- 1721676
- 3007648417
- 2133772
- 2648727
- 1419411
- 2246552
- 3006788678
- 1054811
- 1056129
- 3004024955
- 3006950086
- 2027062
- 3015225571
- 1417485
- 3014004349
- 3015142721
- 3014032451
- 3009423112
- 3012536737
- 2020394
- 3007014520
- 3013440400
- 3022977243
- 3004201275
- 1423662
- 1528319
- 1423537
- 2528981
- 1056553
- 2032098
- 1219114
- 1123169
- 3007200016
- 3010273872
- 3005216725
- 3012447612
- 1721686
- 3010515547
- 1643817
- 1835568
- 2133810
- 9680340
- 3017448139
- 3003500271
- 3008262715
- 3019807891
- 1644312
- 3015806723
- 3015077548
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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