Panels › Gastroenterology, Urology › Product code KNW · Class 2
Instrument, Biopsy
Regulation 876.1075
9510(k)s in 12 months (366 all time)
5recalls in 12 months (107 all time)
103recalls that name a 510(k)
Top companies in KNW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 1998 | K974814 | MANAN(TM) SUPER-CORE BIOPSY NEEDLES Medical Device Technologies, Inc. | KNW |
| Jan 9, 1998 | K973152 | GALLINI ABS DEVICE Gallini U.S., LLC | KNW |
| Jan 8, 1998 | K974766 | MANAN TECHNA-CUT ASPIRATION NEEDLE Medical Device Technologies, Inc. | KNW |
| Jan 8, 1998 | K974446 | MANAN AUTOMATIC CUTTING NEEDLE Manan Medical Products, Inc. | KNW |
| Dec 9, 1997 | K974158 | ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY Ortho Development Corp. | KNW |
| Dec 9, 1997 | K972496 | PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER Tao & Tao Technologyt, Inc. | KNW |
| Dec 1, 1997 | K973496 | THE AUTO SUTURE* MIBB** SYSTEM United States Surgical, A Division of Tyco Healthc | KNW |
| Nov 6, 1997 | K973215 | STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM Laurus Medical Corp. | KNW |
| Nov 3, 1997 | K973565 | QUICK-CARE BIOPSY NEEDLE Cook, Inc. | KNW |
| Oct 9, 1997 | K962977 | MRI COMPATIBLE BIOPSY NEEDLES Manan Medical Products, Inc. | KNW |
| Jul 29, 1997 | K972266 | GALLINI COAXIAL INTRODUCER Gallini U.S., LLC | KNW |
| May 21, 1997 | K970872 | PAN (CHIBA ASPIRATING NEEDLE) Gallini Intl., Inc. | KNW |
| May 21, 1997 | K970871 | TR NEEDLE Gallini Intl., Inc. | KNW |
| Mar 28, 1997 | K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) Biopsys Medical, Inc. | KNW |
| Mar 20, 1997 | K963813 | SURE CORE BIOPSY KIT Interventional Concepts, Inc. | KNW |
| Jan 3, 1997 | K964777 | TZ Gallini Intl., Inc. | KNW |
| Dec 20, 1996 | K963825 | AUTO SUTURE* ABBI* SYSTEM United States Surgical, A Division of Tyco Healthc | KNW |
| Dec 6, 1996 | K962969 | MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA Medical Device Technologies, Inc. | KNW |
| Nov 21, 1996 | K961407 | SPEED-CUT Gallini Intl., Inc. | KNW |
| Oct 23, 1996 | K962907 | SKINNY,FRANSEEN,WESCOTT NEEDLES Baxter Healthcare Corp | KNW |
| Oct 10, 1996 | K963390 | BIOPSY INTRODUCER NEEDLE Baxter Healthcare Corp | KNW |
| Jul 30, 1996 | K962077 | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER C.R. Bard, Inc. | KNW |
| Apr 5, 1996 | K960065 | TEMNO DOUBLE SHOT BIOPSY NEEDLE Bauer Medical, Inc. | KNW |
| Apr 5, 1996 | K960064 | TEMNO ACHIEVE BIOPSY NEEDLE Bauer Medical, Inc. | KNW |
| Apr 4, 1996 | K960509 | 18 GAUGE TRU-CUT BIOPSY NEEDLE Baxter Healthcare Corp | KNW |
| Apr 4, 1996 | K954999 | LILY MULTICANNULA GUIDE Lily Imaging Solutions Co. | KNW |
| Dec 29, 1995 | K954529 | AUTOMATED TRU-CUT BIOPSY DEVICE Baxter Healthcare Corp | KNW |
| Oct 30, 1995 | K953399 | NEEDLE OR CUTTER Biophysic Medical, Inc. | KNW |
| Sep 29, 1995 | K954265 | TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE Promex, Inc. | KNW |
| Sep 15, 1995 | K954151 | BIOACCESS BONE BIOPSY SYSTEM Bioaccess, Inc. | KNW |
| Sep 8, 1995 | K953923 | URESIL INTRODUCING NEEDLE Uresil Corp. | KNW |
| Sep 8, 1995 | K953880 | BIOPSY NEEDLE Biopsys Medical, Inc. | KNW |
| Apr 6, 1995 | K951229 | MODIFIED BIOPSY NEEDLE Biopsys Medical, Inc. | KNW |
| Mar 2, 1995 | K950732 | MANAN SUPER-CORE BIOPSY NEEDLE Manan Medical Products, Inc. | KNW |
| Dec 9, 1994 | K945573 | BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. | KNW |
| Oct 14, 1994 | K944837 | MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE Medical Device Technologies, Inc. | KNW |
| Sep 29, 1994 | K943651 | TECHNA-CUT ASPIRATION NEEDLE Manan Medical Products, Inc. | KNW |
| Aug 26, 1994 | K943650 | LIVER BIOPSY KIT Manan Medical Products, Inc. | KNW |
| Jul 29, 1994 | K943368 | TRU-CORE NEEDLE SET Ideamatrix | KNW |
| Jul 13, 1994 | K941256 | QUICK CORE II Proact, Ltd. | KNW |
| Jul 12, 1994 | K942630 | WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE Mill-Rose Laboratory | KNW |
| Jul 7, 1994 | K942639 | BIOPSY NEEDLE AND HOUSING Biopsys Medical, Inc. | KNW |
| Apr 28, 1994 | K934371 | BIP MULTI MODIFICATION Bip USA, Inc. | KNW |
| Apr 19, 1994 | K941549 | BIOPSY NEEDLE AND HOUSING Biopsys Medical, Inc. | KNW |
| Mar 14, 1994 | K935814 | MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE Boston Scientific Corp | KNW |
| Feb 25, 1994 | K940365 | MANAN ADAPTER FOR BARD BIOPTY SYSTEM Manan Medical Products, Inc. | KNW |
| Nov 12, 1993 | K933448 | MANAN ADAPTER FOR BIP BIOPSY DEVICE Manan Medical Products, Inc. | KNW |
| Jun 9, 1993 | K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM Meadox Surgimed, Inc. | KNW |
| Apr 21, 1993 | K930083 | EMS BIOPSY INSTRUMENT Engineered Medical Systems | KNW |
| Apr 20, 1993 | K930241 | OLYMPUS DISPOSABLE BIOPSY FORCEPS Olympus Corp. | KNW |
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