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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001132 | BONE BIOPSY NEEDLE | Promex, Inc. | 2000-05-01 | Traditional | PDF ↗ |
| K000612 | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE | Inrad | 2000-04-24 | Traditional | PDF ↗ |
| K000135 | PRO.DUCT CATHETER, MODEL CTH03 | Pro. Duct Health, Inc. | 2000-04-10 | Traditional | PDF ↗ |
| K994272 | AUTOMATED CORE BIOPSY DEVICE | Promex, Inc. | 2000-01-07 | Traditional | PDF ↗ |
| K993936 | 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE | Imagyn Surgical | 1999-12-27 | Traditional | PDF ↗ |
| K993342 | DUCPREP BREAST ASPIRATOR, MODEL PMPO2 | Windy Hill Technology, Inc. | 1999-12-23 | Traditional | PDF ↗ |
| K993435 | MANUAL BONE MARROW BIOPSY DEVICE | Promex, Inc. | 1999-12-06 | Traditional | PDF ↗ |
| K992813 | 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT | Ethicon Endo-Surgery, Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K991980 | MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, | Ethicon Endo-Surgery, Inc. | 1999-08-17 | Traditional | PDF ↗ |
| K992499 | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE | Gallini U.S., LLC | 1999-08-12 | Traditional | PDF ↗ |
| K991366 | DAUM MRI/CONVENTIONAL BIOPSY KIT | Daum GmbH | 1999-06-25 | Traditional | PDF ↗ |
| K983867 | FUJI CATHETER, MODEL CTH001 | Windy Hill Technology, Inc. | 1999-06-09 | Traditional | PDF ↗ |
| K983296 | AUTO SUTURE ABBI SYSTEM | United States Surgical, A Division of Tyco Healthc | 1999-06-04 | Traditional | PDF ↗ |
| K990839 | TRU-CORE I REUSABLE BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 1999-05-20 | Traditional | PDF ↗ |
| K990645 | GALLINI ATRA-CUT NEEDLE | Gallini U.S., LLC | 1999-05-19 | Traditional | PDF ↗ |
| K990716 | GALLINI BYCUT NEEDLE | Gallini U.S., LLC | 1999-05-17 | Traditional | PDF ↗ |
| K990515 | MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM | International Medical Systems | 1999-05-13 | Traditional | PDF ↗ |
| K990782 | DAUM NEUROGATE TROCAR | Daum GmbH | 1999-04-28 | Traditional | PDF ↗ |
| K990278 | DAUM NEUROCUT NEUROBIOPSYNEEDLE | Daum Corp. | 1999-03-30 | Traditional | PDF ↗ |
| K983187 | MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE | Medsol Corp. | 1998-12-10 | Traditional | PDF ↗ |
| K982960 | MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT | Medical Device Technologies, Inc. | 1998-09-23 | Traditional | PDF ↗ |
| K982735 | LIGHT SABER BONE BIOPSY NEEDLE | Minrad, Inc. | 1998-09-09 | Traditional | PDF ↗ |
| K982401 | PROSTATE BIOPSY NEEDLE | Remington Medical, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K981796 | LIGHT SABER CORE TISSUE NEEDLE | Minrad, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K981721 | C0-AXIAL INTRODUCER NEEDLE | Inrad | 1998-07-28 | Traditional | PDF ↗ |
| K982085 | MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT | Medical Device Technologies, Inc. | 1998-07-17 | Traditional | PDF ↗ |
| K981301 | SPEED-CUT AUTOMATIC BIOPSY SYSTEM | Gallini U.S., LLC | 1998-07-08 | Traditional | PDF ↗ |
| K972328 | PERCUTANEOUS BREAST BIOPSY (PBB) | Urothealth System, Inc. | 1998-07-07 | Traditional | PDF ↗ |
| K981320 | DAUM BONE BIOPSY SET | Daum Corp. | 1998-06-29 | Traditional | PDF ↗ |
| K981166 | ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 | Inrad | 1998-06-22 | Traditional | PDF ↗ |
| K981477 | MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE | Medical Biopsy, Inc. | 1998-06-10 | Traditional | PDF ↗ |
| K980676 | SPIGAL NEEDLE | Gallini U.S., LLC | 1998-05-21 | Traditional | PDF ↗ |
| K980479 | QUICK-CUT AUTOMATIC BIOPSY SYSTEM | Gallini U.S., LLC | 1998-05-06 | Traditional | PDF ↗ |
| K963794 | PUNCTURENEEDLE | Ferguson Medical | 1998-03-19 | Traditional | PDF ↗ |
| K974631 | DAUM NEUROBIOPSY NEEDLE | Daum Corp. | 1998-03-09 | Traditional | PDF ↗ |
| K974576 | DAUM BIOPSYGUN | Daum Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K974574 | DAUM NEUROPUNCTURE NEEDLE | Daum Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K974575 | DAUM ASPIRATIONBIOPSY NEEDLE | Daum Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K980226 | MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM | Medical Device Technologies, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K980248 | ACRI R NEEDLE | Gallini U.S., LLC | 1998-02-18 | Traditional | PDF ↗ |
| K980452 | MANAN LIVER BIOPSY KIT | Medical Device Technologies, Inc. | 1998-02-18 | Traditional | PDF ↗ |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | Manan Medical Products, Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K980196 | MD TECH BIOPSY SET FOR BONE AND BONE MARROW | Medical Device Technologies, Inc. | 1998-02-03 | Traditional | PDF ↗ |
| K974440 | IBI | Gallini U.S., LLC | 1998-01-30 | Traditional | PDF ↗ |
| K980122 | MANAN SOFT TISSUE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K980068 | WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE | Worldwide Medical Technologies, LLC | 1998-01-23 | Traditional | PDF ↗ |
| K974794 | WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE | Worldwide Medical Technologies, LLC | 1998-01-23 | Traditional | PDF ↗ |
| K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | Telemed Systems, Inc. | 1998-01-21 | Traditional | PDF ↗ |
| K974814 | MANAN(TM) SUPER-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K980004 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | Medical Device Technologies, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K973152 | GALLINI ABS DEVICE | Gallini U.S., LLC | 1998-01-09 | Traditional | PDF ↗ |
| K974766 | MANAN TECHNA-CUT ASPIRATION NEEDLE | Medical Device Technologies, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | Manan Medical Products, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K972496 | PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER | Tao & Tao Technologyt, Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K974158 | ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY | Ortho Development Corp. | 1997-12-09 | Traditional | PDF ↗ |
| K973496 | THE AUTO SUTURE* MIBB** SYSTEM | United States Surgical, A Division of Tyco Healthc | 1997-12-01 | Traditional | PDF ↗ |
| K973215 | STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM | Laurus Medical Corp. | 1997-11-06 | Traditional | PDF ↗ |
| K973565 | QUICK-CARE BIOPSY NEEDLE | Cook, Inc. | 1997-11-03 | Traditional | PDF ↗ |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | Manan Medical Products, Inc. | 1997-10-09 | Traditional | PDF ↗ |
| K972266 | GALLINI COAXIAL INTRODUCER | Gallini U.S., LLC | 1997-07-29 | Traditional | PDF ↗ |
| K970871 | TR NEEDLE | Gallini Intl., Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K970872 | PAN (CHIBA ASPIRATING NEEDLE) | Gallini Intl., Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | Biopsys Medical, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K963813 | SURE CORE BIOPSY KIT | Interventional Concepts, Inc. | 1997-03-20 | Traditional | PDF ↗ |
| K964777 | TZ | Gallini Intl., Inc. | 1997-01-03 | Traditional | PDF ↗ |
| K963825 | AUTO SUTURE* ABBI* SYSTEM | United States Surgical, A Division of Tyco Healthc | 1996-12-20 | Traditional | PDF ↗ |
| K962969 | MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA | Medical Device Technologies, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K961407 | SPEED-CUT | Gallini Intl., Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K962907 | SKINNY,FRANSEEN,WESCOTT NEEDLES | Baxter Healthcare Corp | 1996-10-23 | Traditional | PDF ↗ |
| K963390 | BIOPSY INTRODUCER NEEDLE | Baxter Healthcare Corp | 1996-10-10 | Traditional | PDF ↗ |
| K962077 | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER | C.R. Bard, Inc. | 1996-07-30 | Traditional | PDF ↗ |
| K960065 | TEMNO DOUBLE SHOT BIOPSY NEEDLE | Bauer Medical, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960064 | TEMNO ACHIEVE BIOPSY NEEDLE | Bauer Medical, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960509 | 18 GAUGE TRU-CUT BIOPSY NEEDLE | Baxter Healthcare Corp | 1996-04-04 | Traditional | PDF ↗ |
| K954999 | LILY MULTICANNULA GUIDE | Lily Imaging Solutions Co. | 1996-04-04 | Traditional | PDF ↗ |
| K954529 | AUTOMATED TRU-CUT BIOPSY DEVICE | Baxter Healthcare Corp | 1995-12-29 | Traditional | PDF ↗ |
| K953399 | NEEDLE OR CUTTER | Biophysic Medical, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954265 | TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE | Promex, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K954151 | BIOACCESS BONE BIOPSY SYSTEM | Bioaccess, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K953923 | URESIL INTRODUCING NEEDLE | Uresil Corp. | 1995-09-08 | Traditional | PDF ↗ |
| K953880 | BIOPSY NEEDLE | Biopsys Medical, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K951229 | MODIFIED BIOPSY NEEDLE | Biopsys Medical, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K950732 | MANAN SUPER-CORE BIOPSY NEEDLE | Manan Medical Products, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K945573 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K944837 | MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE | Medical Device Technologies, Inc. | 1994-10-14 | Traditional | PDF ↗ |
| K943651 | TECHNA-CUT ASPIRATION NEEDLE | Manan Medical Products, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K943650 | LIVER BIOPSY KIT | Manan Medical Products, Inc. | 1994-08-26 | Traditional | PDF ↗ |
| K943368 | TRU-CORE NEEDLE SET | Ideamatrix | 1994-07-29 | Traditional | PDF ↗ |
| K941256 | QUICK CORE II | Proact, Ltd. | 1994-07-13 | Traditional | PDF ↗ |
| K942630 | WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE | Mill-Rose Laboratory | 1994-07-12 | Traditional | PDF ↗ |
| K942639 | BIOPSY NEEDLE AND HOUSING | Biopsys Medical, Inc. | 1994-07-07 | Traditional | PDF ↗ |
| K934371 | BIP MULTI MODIFICATION | Bip USA, Inc. | 1994-04-28 | Traditional | PDF ↗ |
| K941549 | BIOPSY NEEDLE AND HOUSING | Biopsys Medical, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K935814 | MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE | Boston Scientific Corp | 1994-03-14 | Traditional | PDF ↗ |
| K940365 | MANAN ADAPTER FOR BARD BIOPTY SYSTEM | Manan Medical Products, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K933448 | MANAN ADAPTER FOR BIP BIOPSY DEVICE | Manan Medical Products, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | Meadox Surgimed, Inc. | 1993-06-09 | Traditional | PDF ↗ |
| K930083 | EMS BIOPSY INSTRUMENT | Engineered Medical Systems | 1993-04-21 | Traditional | PDF ↗ |
| K930241 | OLYMPUS DISPOSABLE BIOPSY FORCEPS | Olympus Corp. | 1993-04-20 | Traditional | PDF ↗ |
| K922939 | BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT. | C.R. Bard, Inc. | 1993-02-16 | Traditional | PDF ↗ |
Product code KNW · Class II · Gastroenterology, Urology. Data: openFDA.