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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2024 | Bard Peripheral Vascular Inc BARD MAGNUM Disposable Core Tissue Biopsy Needle REF:
MN1410
MN 1420
MN1610
MN1616
MN1820
MN2010
The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft Open, Classified |
FCG | K934370 |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B;
2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ;
3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ;
4) BREAST B Open, Classified |
FCG | None listed |
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Open, Classified |
FCG | K210476 |
| May 16, 2024 | Cook Medical Incorporated EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Open, Classified |
FCG | K092359 |
| May 19, 2023 | Olympus Corporation of the Americas To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract
Models: NA-U40 Open, Classified |
FCG | K160098 |
| May 19, 2023 | Olympus Corporation of the Americas ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree Open, Classified |
FCG | K160098 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip
Model Number: T146 Open, Classified |
FCG | K151373 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of Terminated |
FCG | K023272 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and ext Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural les Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesio Terminated |
FCG | K050503 |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions Terminated |
FCG | K050503 |
| Aug 5, 2020 | Covidien Llc Beacon EUS Access System Preloaded Access 135degree Needle
sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula Open, Classified |
FCG | K180037 |
| Aug 5, 2020 | Covidien Llc Beacon EUS Access System Preloaded Access 90degree Needle
sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula Open, Classified |
FCG | K180037 |
| Feb 28, 2017 | Medtronic BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 Terminated |
FCG | K103668 |
| Feb 28, 2017 | Medtronic SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 Terminated |
FCG | K103668 |
| Feb 28, 2017 | Medtronic SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 Terminated |
FCG | K103668 |
| Feb 28, 2017 | Medtronic SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 Terminated |
FCG | K103668 |
| Feb 28, 2017 | Medtronic BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 Terminated |
FCG | K103668 |
| Aug 22, 2016 | Cook Inc. Liver Access and Biopsy Needle Set
Biopsy needle kit
Intended for use in obtaining liver histology samples via a jugular vein approach. Terminated |
FCG | None listed |
| Aug 16, 2016 | Bard Peripheral Vascular Inc Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product
Part Number C1816B
The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy sampl Terminated |
FCG | K936194 |
| Feb 4, 2016 | Bard Peripheral Vascular Inc Bard TruGuide Disposable Coaxial Biopsy Needle
Product Usage:
The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue Terminated |
FCG | K936194 |
| Oct 7, 2011 | Olympus America Inc. OLYMPUS ViziShot EBUS Aspiration Needle
Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically Terminated |
FCG | K050503 |
| Sep 16, 2011 | Boston Scientific Corporation Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO
The Expect Needle is designed to sample targeted submucosal and extram Terminated |
FCG | K100712 K110030 |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal and e Terminated |
FCG | K100712 |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal and e Terminated |
FCG | K100712 |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosa Terminated |
FCG | K100712 |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010, 428
Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal Terminated |
FCG | K100712 |
| Nov 17, 2009 | Bard Peripheral Vascular Inc Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620.
Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney Terminated |
FCG | K934370 |
| Nov 17, 2009 | Bard Peripheral Vascular Inc Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616.
Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney Terminated |
FCG | K934370 |
| Nov 17, 2009 | Bard Peripheral Vascular Inc Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613.
Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney Terminated |
FCG | K934370 |
| Nov 17, 2009 | Bard Peripheral Vascular Inc Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610.
Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney Terminated |
FCG | K934370 |
| Nov 9, 2009 | Cardinal Health Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000 Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1215, REF M00512150 and M00512151.
For use to endoscopically or percutaneously ret Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1213, REF M00512130 and M00512131.
For use to endoscopically or percutaneously ret Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-115, REF M0065001150 and M0065001151.
For use to endoscopically or percutaneousl Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-114, REF M0065001140 and M0065001141.
For use to endoscopically or percutaneousl Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081.
For use to endoscopically or percutaneousl Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-107, REF M0065001070 and M0065001071.
For use to endoscopically or percutaneous Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061.
For use to endoscopically or percutaneo Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-105, REF M0065001050 and M0065001051.
For use to endoscopically or percutaneou Terminated |
FCG | K040893 |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-104, REF M0065001040 and M0065001041.
For use to endoscopically or percutaneou Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, Sterilized with ethylene oxide gas. UPN for inner pouch M001434600.
M001434601
43-460
Indicated for use endo Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591, Sterilized with ethylene oxide gas. UPN for inner pouch M001434590.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, Sterilized with ethylene oxide gas. UPN for inner pouch M001434580.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561, Sterilized with ethylene oxide gas. UPN for inner pouch M001434560.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541, Sterilized with ethylene oxide gas. UPN for inner pouch M001434540.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas.
UPN for inner pouch M001434530.
Indicated for use endoscopically or percutan Terminated |
FCG | K040893 |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511, Sterilized with ethylene oxide gas. UPN for inner pouch M001434510.
Indicated for use endoscopically or percu Terminated |
FCG | K040893 |
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