FDA 510(k) Applications for Medical Device Product Code "FIE"
(Needle, Fistula)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K112734 | APLAN WELL ENTERPRISE CO., LTD | APLAN A.V. FISTULA NEEDLE SET | 04/24/2012 |
| K163025 | Bain Medical Equipment (Guangzhou) Co., Ltd. | DORA Disposable A.V. Fistula Needle Sets | 07/20/2017 |
| K213015 | Bain Medical Equipment (Guangzhou)Co., Ltd. | DORA Disposable A.V. Fistula Needle Sets | 04/08/2022 |
| K993118 | BIOTEQUE CORP. | BIOTEQUE A.V. FISTULA NEEDLE SET | 12/17/1999 |
| K992653 | DIASOL, INC. | SHELLY PROTECTED AV FISTULA NEEDLE | 10/27/1999 |
| K171505 | Dimesol, Inc. | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | 05/17/2018 |
| K001496 | EXELINT INTERNATIONAL CO. | A.V. FISTULA NEEDLE | 08/01/2000 |
| K013037 | EXELINT INTL. CO. | EXCEL A.V FISUTAL NEEDLE SET | 12/07/2001 |
| K023162 | FRESENIUS MEDICAL CARE | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | 03/20/2003 |
| K990470 | JMS CO., LTD. | JMS A. V. FISTULA NEEDLE SET | 08/30/1999 |
| K002352 | JMS CO., LTD. | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | 09/06/2001 |
| K974902 | JMS CO., LTD. | JMS APHERESIS NEEDLE | 03/30/1998 |
| K990510 | JMS CO., LTD. | JMS APHERESIS NEEDLE | 08/30/1999 |
| K970962 | JMS CO., LTD. | JMS AV FISTULA NEEDLE | 08/07/1997 |
| K000845 | JMS CO., LTD. | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | 04/10/2000 |
| K000843 | JMS CO., LTD. | MODIFICATION TO JMS APHERESIS NEEDLE | 04/10/2000 |
| K082882 | JMS NORTH AMERICA CORP. | A.V. FISTULA BLUNT NEEDLE SET | 01/21/2009 |
| K093637 | JMS NORTH AMERICA CORP. | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | 02/09/2010 |
| K051814 | JMS NORTH AMERICA CORP. | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET | 08/04/2005 |
| K040247 | JMS NORTH AMERICA CORP. | PLUME SAFETY AVF NEEDLE | 03/03/2004 |
| K112178 | JMS NORTH AMERICA CORPORATION | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | 10/27/2011 |
| K151017 | JMS NORTH AMERICA CORPORATION | JMS Harmony A.V. Fistula Needle Set | 05/13/2015 |
| K142564 | JMS North America Corporation | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | 12/23/2014 |
| K110157 | JMS NORTH AMERICA CORPORATION | SYSLOC MINI V3 | 02/11/2011 |
| K111948 | JMS NORTH AMERICA CORPORATION | WINGEATER V2 | 10/24/2011 |
| K062953 | MEDISYSTEMS CORP. | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | 02/12/2007 |
| K990803 | MEDISYSTEMS CORP. | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | 01/06/2000 |
| K991623 | NIPRO MEDICAL CORP. | NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA | 08/09/1999 |
| K063368 | NIPRO MEDICAL CORP. | NIPRO BIOHOLE NEEDLE | 02/05/2007 |
| K063721 | NIPRO MEDICAL CORP. | NIPRO SAFETOUCH II GAMMA | 01/12/2007 |
| K093985 | NIPRO MEDICAL CORP. | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | 01/22/2010 |
| K002813 | NIPRO MEDICAL CORP. | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE | 11/21/2000 |
| K100520 | NIPRO MEDICAL CORPORATION | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | 03/17/2010 |
| K955182 | NISSHO CORP. | NIPRO ARTERIAL VENOUS FISTULA NEEDLE | 06/04/1996 |
| K134019 | NXSTAGE MEDICAL, INC. | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | 09/11/2014 |
| K013384 | SHARGH PHARMACEUTICAL CO., INC. | SHARGHP A.V. FISTULA NEEDLE SET | 01/07/2002 |
| K131950 | SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | 01/16/2015 |
| K003123 | SUNDER BIOMEDICAL TECH. CO., LTD. | RENAX A.V. FISTULA NEEDLE SETS | 05/04/2001 |
| K052267 | TOGO MEDIKIT CO., LTD. | SUPERCATH V | 10/27/2006 |
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