510(k) K914874
- Device
- MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE
- Applicant
- MANAN MEDICAL PRODUCTS, INC.
- 510(k) number
- K914874
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-18
- Date received
- 1991-10-29
- 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
- MANFRED MITTERMEIER
- Address
- 2200 Carlson Dr. Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3005580113
- 1721686
- 1211566
- 3015974593
- 1625685
- 1423507
- 1219114
- 3010041511
- 3010419931
- 1721676
- 3022977243
- 3007648417
- 3013188547
- 3006330030
- 3007162296
- 1423662
- 1319639
- 1644312
- 3010097171
- 3044026004
- 3014004349
- 3011088743
- 1835568
- 2246552
- 3010381606
- 3015967359
- 3006082230
- 1921846
- 3015077548
- 2133810
- 9617616
- 3015225571
- 1724474
- 3011642792
- 1424263
- 3004024955
- 3016678045
- 3011504993
- 3010220595
- 1423537
- 1000484830
- 2320767
- 1721504
- 9680794
- 1721983
- 1123169
- 3015142721
- 1018233
- 3015309643
- 3018094310
- 3006786907
- 3011245468
- 3004774118
- 9680904
- 2183613
- 3008492462
- 1037885
- 1643817
- 3038611181
- 1000393132
- 3007748770
- 3005636544
- 3002806603
- 3008992312
- 3002808022
- 1058584
- 3010082909
- 3013462478
- 3008496839
- 2134812
- 3030733800
- 3013727803
- 3007137598
- 3030626857
- 1061124
- 3006950086
- 3000126629
- 3008044552
- 3033589330
- 1000112137
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#
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
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