FDA Product Code
FDA Product Code KNW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 365 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133702 | PRESTO BREAST BIOPSY DEVICE | Sontina Medical, LLC | 2014-02-28 | Special | PDF ↗ |
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | Bard Peripheral Vascular, Inc. | 2014-02-21 | Special | PDF ↗ |
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES | Biopsybell S.R.L. | 2014-02-07 | Traditional | PDF ↗ |
| K131157 | RANFAC BONE MARROW ASPIRATION NEEDLE | Ranfac, Corp. | 2013-10-22 | Traditional | PDF ↗ |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | Remington Medical, Inc. | 2013-05-13 | Traditional | PDF ↗ |
| K123606 | CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE | Scion Medical Technologies, LLC | 2013-03-01 | Special | PDF ↗ |
| K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM | Devicor Medical Products, Inc. | 2012-11-15 | Traditional | PDF ↗ |
| K121181 | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE | Alliance Partners, LLC | 2012-08-22 | Traditional | PDF ↗ |
| K120002 | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | Busse Hospital Disposables, Inc. | 2012-06-26 | Traditional | PDF ↗ |
| K120440 | PRESTO BREAST BIOPSY DEVICE | Sontina Medical, LLC | 2012-05-17 | Traditional | PDF ↗ |
| K112411 | MAMMOTOME ELITE BIOPSY SYSTEM | Devicor Medical Products, Inc. | 2012-03-20 | Traditional | PDF ↗ |
| K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE | Vidacare Corporation | 2012-03-08 | Traditional | PDF ↗ |
| K120189 | BONETRAP | Berni Farns Incorporated | 2012-02-22 | Traditional | PDF ↗ |
| K102756 | SURECORE BIOPSY DEVICE | Chest Innovations, Inc. | 2011-11-29 | Traditional | PDF ↗ |
| K113209 | CHIBA SONO | Pajunk GmbH | 2011-11-21 | Traditional | PDF ↗ |
| K112945 | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM | Inrad, Inc. | 2011-11-03 | Special | PDF ↗ |
| K112468 | THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE | Regulatory Specialists, Inc. | 2011-10-20 | Traditional | PDF ↗ |
| K111765 | FULL CORE BIOPSY SYSTEM | Promex Technologies, LLC | 2011-09-06 | Traditional | PDF ↗ |
| K111529 | MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- | Insert Molding Solutions, Inc. | 2011-07-29 | Traditional | PDF ↗ |
| K102771 | BIOPSY HANDY, MRI BIOPSY HANDY | Somatex Medical Technologies GmbH | 2011-06-24 | Traditional | PDF ↗ |
| K111100 | ENCOR ENSPIRE BREAST BIOPSY SYSTEM | C.R. Bard, Inc. | 2011-06-16 | Special | PDF ↗ |
| K110883 | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA | Busse Hospital Disposables | 2011-06-08 | Traditional | PDF ↗ |
| K092338 | MEDAX UNIPERSONALE SRL | Medax Unipersonale Srl | 2011-05-27 | Traditional | PDF ↗ |
| K103359 | FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) | C.R. Bard, Inc. | 2010-12-27 | Special | PDF ↗ |
| K101832 | BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 2010-08-27 | Traditional | PDF ↗ |
| K093899 | MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING | Ethicon Endo-Surgery, LLC | 2010-04-29 | Traditional | PDF ↗ |
| K093512 | ENCOR BREAST BIOPSY SYSTEM | Senorx, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K093399 | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 | Inrad | 2009-11-19 | Traditional | PDF ↗ |
| K093256 | SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 | Inrad | 2009-11-17 | Traditional | PDF ↗ |
| K093068 | FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US | C.R. Bard, Inc. | 2009-11-10 | Traditional | PDF ↗ |
| K092059 | RP CUTTING NEEDLE | Riverpoint Medical | 2009-09-24 | Traditional | PDF ↗ |
| K090611 | REVOLUTION FULL CORE BIOPSY | Inrad | 2009-06-04 | Traditional | PDF ↗ |
| K082681 | VACORA VACUUM ASSISTED BIOPSY SYSTEM | C.R. Bard, Inc. | 2008-10-15 | Special | PDF ↗ |
| K081057 | INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL | Intact Medical Corporation | 2008-06-17 | Traditional | PDF ↗ |
| K080095 | CORAMATE/SPIROTOME SYSTEM | Medinvents | 2008-04-11 | Traditional | PDF ↗ |
| K080171 | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 | Sanarus Medical, Inc. | 2008-03-06 | Traditional | PDF ↗ |
| K072045 | ONCONTROL BONE MARROW BIOPSY SYSTEM | Vidacare Corporation | 2007-10-22 | Traditional | PDF ↗ |
| K071814 | LIGHT SABRE SPINAL ACCESS DEVICE | Minrad, Inc. | 2007-10-16 | Traditional | PDF ↗ |
| K071048 | RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 | Rubicor Medical, Inc. | 2007-05-15 | Special | PDF ↗ |
| K063233 | DELTACUT (APPARATUS AND CANNULA) | PAJUNK GmbH Medizintechnologie | 2007-04-30 | Traditional | PDF ↗ |
| K070091 | COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007-04-18 | Traditional | PDF ↗ |
| K063697 | SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT | PAJUNK GmbH Medizintechnologie | 2007-02-14 | Traditional | PDF ↗ |
| K062832 | VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 | C.R. Bard, Inc. | 2006-10-20 | Special | PDF ↗ |
| K060384 | CORAMATE/SPIROTOME SYSTEM | Medinvents | 2006-07-13 | Traditional | PDF ↗ |
| K061570 | I-STYLE BONE MARROW ASPIRATION NEEDLE | Busse Hospital Disposables, Inc. | 2006-07-03 | Traditional | PDF ↗ |
| K060413 | INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE | Intact Medical Corporation | 2006-04-27 | Traditional | PDF ↗ |
| K053151 | RUBICOR MAGIC BREAST BIOPSY DEVICE | Rubicor Medical, Inc. | 2005-11-18 | Traditional | PDF ↗ |
| K052638 | ABBOTT SPINE, INC. SPINNAKER SYSTEM | Abbott Spine, Inc. | 2005-11-07 | Traditional | PDF ↗ |
| K052435 | PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS | Pneumrx, Inc. | 2005-11-03 | Traditional | PDF ↗ |
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | Manan Medical Products, Inc. | 2005-11-01 | Special | PDF ↗ |
| K051581 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 | Sanarus Medical, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K051361 | EASY CORE DETACHABLE BIOPSY SYSTEM | Boston Scientific Corp | 2005-06-16 | Special | PDF ↗ |
| K050795 | IMBIBE BONE MARROW ASPIRATION NEEDLE | Orthovita, Inc. | 2005-06-03 | Traditional | PDF ↗ |
| K051158 | ENCOR 7 GAUGE | Senorx, Inc. | 2005-05-16 | Special | PDF ↗ |
| K043523 | INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE | Medical Device Technologies, Inc. | 2005-02-11 | Traditional | PDF ↗ |
| K042753 | MAMMOTOME MR BIOPSY SYSTEM | Ethicon Endo-Surgery, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K042290 | VACUUM ASSISTED CORE BIOPSY DEVICE | Suros Surgical Systems, Inc. | 2004-10-06 | Traditional | PDF ↗ |
| K042464 | V-CORE FULL CORE BREAST BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 2004-09-30 | Traditional | PDF ↗ |
| K042136 | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2004-09-08 | Special | PDF ↗ |
| K034021 | VACUUM ASSISTED CORE BIOPSY DEVICE | Suros Surgical Systems, Inc. | 2004-09-08 | Traditional | PDF ↗ |
| K041544 | COOK SIDEARM CORE TISSUE BIOPSY DEVICE | Urological, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K040266 | CORE NEEDLE BIOPSY | Remington Medical, Inc. | 2004-07-09 | Traditional | PDF ↗ |
| K040842 | SENORX BIOPSY DEVICE II | Senorx, Inc. | 2004-04-30 | Special | PDF ↗ |
| K040087 | RABBIT | Scion International, Inc. | 2004-04-01 | Traditional | PDF ↗ |
| K033616 | TRAPMATIC SYSTEM SET | H.S Hospital Service S.P.A | 2004-03-01 | Traditional | PDF ↗ |
| K033700 | MAMMOTOME EX HAND HELD SYSTEM | Ethicon Endo-Surgery, Inc. | 2004-02-20 | Traditional | PDF ↗ |
| K032943 | STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS | Stryker Corp. | 2003-12-17 | Traditional | PDF ↗ |
| K033427 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2003-11-10 | Special | PDF ↗ |
| K032506 | SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K030472 | MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM | Ethicon Endo-Surgery, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K032847 | EXCISOR BIOPTOME, MODEL 01-0004 | Acueity, Inc. | 2003-09-26 | Traditional | PDF ↗ |
| K031344 | RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE | Ranfac, Corp. | 2003-05-23 | Traditional | PDF ↗ |
| K030443 | MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST | Nastech Pharmaceutical Company, Inc. | 2003-05-09 | Traditional | PDF ↗ |
| K024089 | VACUFLASH BIOPSY SYSTEM | Bip USA, Inc. | 2003-03-11 | Traditional | PDF ↗ |
| K023923 | SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE | Senorx, Inc. | 2002-12-11 | Special | PDF ↗ |
| K022286 | ENCIRCLE LOCALIZATION DEVICE | Vivant Medical, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K020848 | NAFD 100 | Neomatrix, LLC | 2002-09-23 | Traditional | PDF ↗ |
| K022879 | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY | Sanarus Medical, Inc. | 2002-09-23 | Special | PDF ↗ |
| K021707 | SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS | Senorx, Inc. | 2002-08-14 | Traditional | PDF ↗ |
| K022169 | CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES | Parallax Medical, Inc. | 2002-07-25 | Special | PDF ↗ |
| K021137 | SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM | Sanarus Medical, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K020987 | BMN I TYPE MARROW ASPIRATION NEEDLE | H.S. Hospital Service S.R.L. | 2002-06-25 | Traditional | PDF ↗ |
| K020867 | BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL | Worldwide Medical Technologies, LLC | 2002-05-20 | Traditional | PDF ↗ |
| K013108 | BIOSUC | Hakko Medical Co., Ltd. | 2002-04-04 | Traditional | PDF ↗ |
| K020024 | CARIS MINITOME BIOPSY INSTRUMENT | Artemis Medical, Inc. | 2002-04-03 | Traditional | PDF ↗ |
| K013692 | TRAPSYSTEM SET | H.S. Hospital Service S.R.L. | 2002-02-05 | Traditional | PDF ↗ |
| K012088 | NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT | Nastech Pharmaceutical Company, Inc. | 2001-12-18 | Traditional | PDF ↗ |
| K012023 | ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE | Senorx, Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012224 | SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW | Ranfac, Corp. | 2001-08-22 | Traditional | PDF ↗ |
| K010735 | SPEEDYBELL | Biopsybell S.A.S. | 2001-08-17 | Traditional | PDF ↗ |
| K011575 | 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 | Imagyn Surgical | 2001-08-17 | Traditional | PDF ↗ |
| K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE | Promex, Inc. | 2001-07-24 | Traditional | PDF ↗ |
| K011206 | PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES | Parallax Medical, Inc. | 2001-07-18 | Abbreviated | PDF ↗ |
| K011104 | OSTEOBELL | Biopsybell S.A.S. | 2001-05-31 | Traditional | PDF ↗ |
| K003528 | SANARUS CORE TISSUE BIOPSY SYSTEM | Endocare, Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K010037 | DAUM DOUBLE-SHOOT BISOPSY GUN | Daum GmbH | 2001-03-22 | Traditional | PDF ↗ |
| K003297 | MAMMOTOME HAND HELD PROBE, MODEL MHH8 | Ethicon Endo-Surgery, Inc. | 2001-01-18 | Traditional | PDF ↗ |
| K003439 | VIVANT BREAST LESION LOCALIZATION DEVICE | Vivant Medical, Inc. | 2000-12-15 | Traditional | PDF ↗ |
| K003370 | JAMSHIDI MARROW ACQUISITION CRADLE | Allegiance Healthcare Corp. | 2000-11-22 | Special | PDF ↗ |
| K002546 | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE | CIVCO Medical Instruments Co., Inc. | 2000-10-31 | Traditional | PDF ↗ |
Product code KNW · Class II · Gastroenterology, Urology. Data: openFDA.