Panels › Gastroenterology, Urology › Product code FCG · Class 2
Biopsy Needle
Regulation 876.1075
0510(k)s in 12 months (133 all time)
0recalls in 12 months (54 all time)
51recalls that name a 510(k)
Top companies in FCG
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 5 | 24 |
| Bard Peripheral Vascular Inc | 0 | 8 |
| Cook Ireland, Ltd. | 7 | 0 |
| Medi-Globe Corp. | 7 | 0 |
| Olympus Medical Systems Corp. | 7 | 0 |
| Wilson-Cook Medical, Inc. | 5 | 1 |
| Aomori Olympus Co., Ltd. | 0 | 5 |
| Medtronic | 0 | 5 |
| H.S. Hospital Service S.R.L. | 4 | 0 |
| H.S. Hospital Services S.P.A. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 2005 | K050120 | EASY CORE BIOPSY SYSTEM II Boston Scientific Corp | FCG |
| May 6, 2004 | K040893 | EASY CORE BIOPSY SYSTEM Boston Scientific Corp | FCG |
| Jan 15, 2003 | K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES Allegiance Healthcare Corp. | FCG |
| Dec 23, 2002 | K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H The Olympus Optical Co. | FCG |
| Sep 3, 2002 | K021847 | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES Biopsy Sciences, LLC | FCG |
| Jul 12, 2002 | K021525 | TOPCUT H.S. Hospital Service S.R.L. | FCG |
| Mar 12, 2002 | K013109 | SONOPSY Hakko Medical Co., Ltd., JP | FCG |
| Dec 12, 2001 | K013071 | SECURCUT ASPIRATION BIOPSY NEEDLE H.S. Hospital Services S.P.A. | FCG |
| Dec 12, 2001 | K013070 | JAMSHIDI BIOPSY NEEDLE H.S. Hospital Services S.P.A. | FCG |
| Dec 12, 2001 | K013069 | BIOSPEED H.S. Hospital Services S.P.A. | FCG |
| Oct 24, 2001 | K012864 | INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 Boston Scientific Corp | FCG |
| Oct 19, 2001 | K013356 | WILSON-COOK ULTRASOUND BIOPSY NEEDLE Wilson-Cook Medical, Inc. | FCG |
| Oct 15, 2001 | K012358 | CHIBA NEEDLE Ispg, Inc. | FCG |
| Jun 27, 2001 | K011075 | EASYBELL Biopsybell S.A.S. | FCG |
| Jun 22, 2001 | K011270 | AUTOMATED CORE BIOPSY DEVICE Promex, Inc. | FCG |
| Dec 19, 2000 | K002947 | BIOMOL ASPIRATION BIOPSY NEEDLE H.S. Hospital Service S.R.L. | FCG |
| Dec 19, 2000 | K002946 | SILENT BIOPSY NEEDLE H.S. Hospital Service S.R.L. | FCG |
| Dec 19, 2000 | K002944 | PRECISA BIOPSY NEEDLE H.S. Hospital Service S.R.L. | FCG |
| Nov 3, 1999 | K991672 | OLYMPUS NA-10J-KB ASPIRATION NEEDLE Olympus America, Inc. | FCG |
| Mar 31, 1999 | K990220 | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM Medi-Globe Corp. | FCG |
| Nov 6, 1998 | K983218 | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE Avid N.I.T., Inc. | FCG |
| Jul 31, 1998 | K981889 | WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE Worldwide Medical Technologies, LLC | FCG |
| Jul 14, 1997 | K963565 | MRI NEEDLES Cook, Inc. | FCG |
| Jun 20, 1997 | K971842 | COAXIAL NEEDLE United States Endoscopy Group, Inc. | FCG |
| Apr 11, 1997 | K970563 | OLYMPUS NA-10J-1 ASPIRATION NEEDLE Olympus America, Inc. | FCG |
| Mar 11, 1997 | K963894 | SMARTGUIDE Ferguson Medical | FCG |
| Jan 29, 1997 | K961897 | WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE Wilson-Cook Medical, Inc. | FCG |
| Nov 27, 1996 | K962570 | ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE Gallini Intl., Inc. | FCG |
| Nov 27, 1996 | K962569 | BIOMID BONE MARROW BIOPSY NEEDLE Gallini Intl., Inc. | FCG |
| Nov 25, 1996 | K962568 | ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES Gallini Intl., Inc. | FCG |
| Oct 11, 1996 | K962905 | TX BIOPSY NEEDLE Gallini S.R.L. | FCG |
| Apr 30, 1996 | K961185 | DAUM BIOPSYNEEDLE Ferguson Medical | FCG |
| Mar 15, 1996 | K960317 | LAURUS NEEDLE CORE BIOPSY SYSTEM Laurus Medical Corp. | FCG |
| Dec 20, 1995 | K943304 | 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY Olympus America, Inc. | FCG |
| Nov 16, 1995 | K951421 | GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES Global Medical Products, Ltd. | FCG |
| Oct 7, 1995 | K954596 | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM Promedical , Ltd. | FCG |
| Sep 22, 1995 | K954231 | AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT Promex, Inc. | FCG |
| Sep 12, 1995 | K954155 | GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. | FCG |
| May 22, 1995 | K941722 | FNA BIOPSY NEEDLE Betta Medical, Inc. | FCG |
| Apr 21, 1995 | K951598 | PRO-B BIOPSY NEEDLE Promedical , Ltd. | FCG |
| Apr 4, 1995 | K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE B. Braun of America, Inc. | FCG |
| Mar 6, 1995 | K950810 | RUTNER BIOPSY DEVICE Cook Urological, Inc. | FCG |
| Feb 13, 1995 | K935844 | GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA Medi-Globe Corp. | FCG |
| Feb 7, 1995 | K945813 | BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP Bd Becton Dickinson Vacutainer Systems Preanalytic | FCG |
| Feb 1, 1995 | K945921 | ECHO STAR NEEDLE SET Ideamatrix | FCG |
| Dec 21, 1994 | K945146 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE Promex, Inc. | FCG |
| Dec 21, 1994 | K944944 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE Promedical , Ltd. | FCG |
| Nov 9, 1994 | K945133 | MODIFIED BIOPSY NEEDLE Biopsys Medical, Inc. | FCG |
| Sep 26, 1994 | K941563 | THE BIOPSY TOOL Citation Medical Corp. | FCG |
| Mar 28, 1994 | K934256 | GLOBAL MEDICAL CUTTING BIOPSY NEEDLE Global Medical Prods, Inc., VG | FCG |
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