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)
Top companies in KNW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Feb 2, 2017 | Medtronic 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 |
KNW | K003190 |
| Nov 8, 2016 | Teleflex 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 |
KNW | K142377 |
| Nov 8, 2016 | Teleflex 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 |
KNW | K142377 |
| Nov 8, 2016 | Teleflex 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 |
KNW | K113872 |
| Nov 8, 2016 | Teleflex 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 |
KNW | K142377 |
| Nov 8, 2016 | Teleflex 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 |
KNW | K142377 |
| Sep 21, 2016 | Hologic, Inc Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. Terminated |
KNW | K150169 |
| Jul 21, 2015 | Argon 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 |
KNW | K980196 |
| Jul 21, 2015 | Argon 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 |
KNW | None listed |
| Jul 18, 2015 | Stryker 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 |
KNW | None listed |
| May 26, 2015 | Stryker 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 |
KNW | K112945 |
| May 6, 2015 | Bard 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 |
KNW | K133948 |
| Apr 14, 2015 | Bard 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 |
KNW | K133948 |
| Jan 7, 2015 | Orthovita, 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 |
KNW | K140414 |
| Jan 7, 2015 | Orthovita, 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 |
KNW | None listed |
| Oct 24, 2014 | Cook 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 |
KNW | K060384 K080095 |
| Oct 28, 2013 | Atossa 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 |
KNW | K030443 |
| Oct 9, 2012 | Remington 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 |
KNW | K982401 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820M, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1820MLL, 18ga (1.3mm) x 20cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Mar 7, 2011 | Remington Medical Inc. Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-14010MLL, 14ga (2.1mm) x 10cm (10), Remington Medical, Inc. Terminated |
KNW | K040266 |
| Aug 26, 2010 | Hologic, 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 |
KNW | K010400 K042290 |
| Jul 13, 2010 | Medical 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 |
KNW | K881957 |
| Jul 13, 2010 | Medical 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 |
KNW | K980196 |
| Jul 13, 2010 | Medical 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 |
KNW | K980226 |
| Mar 18, 2010 | Hologic, 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 |
KNW | K010400 K042290 |
| Jan 6, 2009 | Medical Device Technologies, Inc. Angiotech, Bone Marrow Harvest Needle, Medical Device Technologies, Inc. The device is intended for use Bone Marrow Biopsy. Terminated |
KNW | K980196 |
| Jan 6, 2009 | Medical 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 |
KNW | K980196 |
| Jan 6, 2009 | Medical Device Technologies, Inc. Angiotech, Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy. Terminated |
KNW | K980196 |
| Jan 6, 2009 | Medical Device Technologies, Inc. Angiotech, Bone Marrow Aspiration Needle, Medical Device Technologies, Inc. Individual packaged in blister pack. Packaged 10 per box. Sterile. Terminated |
KNW | K980196 |
| Nov 18, 2008 | Theken 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 |
KNW | K993435 |
| Nov 7, 2008 | Hologic, 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 |
KNW | K010400 K042290 |
| Oct 22, 2008 | Bard Peripheral Vascular Inc Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140. Terminated |
KNW | K062832 |
| Mar 29, 2007 | Remington 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 |
KNW | K982401 |
| Jan 23, 2007 | Suros 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 |
KNW | K010400 K042290 |
| Jun 22, 2006 | Suros Surgical Systems Inc. ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09. Terminated |
KNW | K010400 |
| Apr 8, 2005 | Remington 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 |
KNW | K982401 |
| Jan 27, 2005 | Ethicon Endo-Surgery Mammotome EX Holster Terminated |
KNW | K033700 |
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