ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNW · Class 2

Instrument, Biopsy

Regulation 876.1075

8510(k)s in 12 months (365 all time)
5recalls in 12 months (107 all time)
103recalls that name a 510(k)
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Top companies in KNW

DateFirm and productCodeLinked 510(k)
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Feb 2, 2017Medtronic Advanced Energy, LLC
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination
Terminated
KNWK003190
Nov 8, 2016Teleflex Medical
ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric pati
Terminated
KNWK142377
Nov 8, 2016Teleflex Medical
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patient
Terminated
KNWK142377
Nov 8, 2016Teleflex Medical
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Terminated
KNWK113872
Nov 8, 2016Teleflex Medical
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatri
Terminated
KNWK142377
Nov 8, 2016Teleflex Medical
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the
Terminated
KNWK142377
Sep 21, 2016Hologic, Inc
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Terminated
KNWK150169
Jul 21, 2015Argon Medical Devices, Inc
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1
Terminated
KNWK980196
Jul 21, 2015Argon Medical Devices, Inc
Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI
Terminated
KNWNone listed
Jul 18, 2015Stryker Instruments Div. of Stryker Corporation
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, brea
Terminated
KNWNone listed
May 26, 2015Stryker Instruments Div. of Stryker Corporation
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Terminated
KNWK112945
May 6, 2015Bard Peripheral Vascular Inc
BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several
Terminated
KNWK133948
Apr 14, 2015Bard Peripheral Vascular Inc
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopt
Terminated
KNWK133948
Jan 7, 2015Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-
Terminated
KNWK140414
Jan 7, 2015Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gau
Terminated
KNWNone listed
Oct 24, 2014Cook Medical Incorporated
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle tha
Terminated
KNWK060384
K080095
Oct 28, 2013Atossa Genetics, Inc.
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, B
Terminated
KNWK030443
Oct 9, 2012Remington Medical Inc.
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and a
Terminated
KNWK982401
Mar 7, 2011Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
Terminated
KNWK040266
Mar 7, 2011Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
Terminated
KNWK040266
Mar 7, 2011Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc.
Terminated
KNWK040266
Mar 7, 2011Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc.
Terminated
KNWK040266
Mar 7, 2011Remington Medical Inc.
Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc.
Terminated
KNWK040266
Aug 26, 2010Hologic, Inc.
Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to th
Terminated
KNWK010400
K042290
Jul 13, 2010Medical Device Technologies, Inc.
Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guid
Terminated
KNWK881957
Jul 13, 2010Medical Device Technologies, Inc.
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesvil
Terminated
KNWK980196
Jul 13, 2010Medical Device Technologies, Inc.
Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014
Terminated
KNWK980226
Mar 18, 2010Hologic, Inc.
ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278.
Terminated
KNWK010400
K042290
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy.
Terminated
KNWK980196
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Terminated
KNWK980196
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Terminated
KNWK980196
Jan 6, 2009Medical Device Technologies, Inc.
Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile.
Terminated
KNWK980196
Nov 18, 2008Theken Spine LLC
Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0))
Terminated
KNWK993435
Nov 7, 2008Hologic, Inc.
ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete removal of tissue sampl
Terminated
KNWK010400
K042290
Oct 22, 2008Bard Peripheral Vascular Inc
Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
Terminated
KNWK062832
Mar 29, 2007Remington Medical Inc.
Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
Terminated
KNWK982401
Jan 23, 2007Suros Surgical Systems Inc.
Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no
Terminated
KNWK010400
K042290
Jun 22, 2006Suros Surgical Systems Inc.
ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
Terminated
KNWK010400
Apr 8, 2005Remington Medical Inc.
Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
Terminated
KNWK982401
Jan 27, 2005Ethicon Endo-Surgery
Mammotome EX Holster
Terminated
KNWK033700

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