Panels › Gastroenterology, Urology › Product code FIE · Class 2
Needle, Fistula
Regulation 876.5540
1510(k)s in 12 months (80 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in FIE
| Company | 510(k)s | Recalls |
|---|---|---|
| Jms Co., Ltd. | 12 | 0 |
| JMS North America Corporation | 10 | 0 |
| Medisystems Corp. | 6 | 1 |
| Nipro Medical Corp. | 6 | 0 |
| Sorensen Research | 6 | 0 |
| Hospal Medical Corp. | 4 | 0 |
| HK Surgical Inc | 0 | 3 |
| Bain Medical Equipment (Guangzhou) Co., Ltd. | 2 | 0 |
| Medisystems a NX Stage Company | 0 | 2 |
| Terumo America, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 2026 | K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Refl Mozarc Medical Us, LLC | FIE |
| Aug 15, 2025 | K251877 | JMS CAVEO A.V. Fistula Needle Set JMS North America Corporation | FIE |
| Apr 8, 2022 | K213015 | DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FIE |
| May 17, 2018 | K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series Dimesol, Inc. | FIE |
| Jul 20, 2017 | K163025 | DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd., CN | FIE |
| May 13, 2015 | K151017 | JMS Harmony A.V. Fistula Needle Set JMS North America Corporation | FIE |
| Jan 16, 2015 | K131950 | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET Summit International Medical Technologies, Inc. | FIE |
| Dec 23, 2014 | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation | FIE |
| Sep 11, 2014 | K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO Nxstage Medical, Inc. | FIE |
| Apr 24, 2012 | K112734 | APLAN A.V. FISTULA NEEDLE SET Aplan Well Enterprise Co., Ltd., TW | FIE |
| Oct 27, 2011 | K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 JMS North America Corporation | FIE |
| Oct 24, 2011 | K111948 | WINGEATER V2 JMS North America Corporation | FIE |
| Feb 11, 2011 | K110157 | SYSLOC MINI V3 JMS North America Corporation | FIE |
| Mar 17, 2010 | K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER Nipro Medical Corporation | FIE |
| Feb 9, 2010 | K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 Jms North America Corp. | FIE |
| Jan 22, 2010 | K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE Nipro Medical Corp. | FIE |
| Jan 21, 2009 | K082882 | A.V. FISTULA BLUNT NEEDLE SET Jms North America Corp. | FIE |
| Feb 12, 2007 | K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE Medisystems Corp. | FIE |
| Feb 5, 2007 | K063368 | NIPRO BIOHOLE NEEDLE Nipro Medical Corp. | FIE |
| Jan 12, 2007 | K063721 | NIPRO SAFETOUCH II GAMMA Nipro Medical Corp. | FIE |
| Oct 27, 2006 | K052267 | SUPERCATH V Togo Medikit Co., Ltd., JP | FIE |
| Aug 4, 2005 | K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET Jms North America Corp. | FIE |
| Mar 3, 2004 | K040247 | PLUME SAFETY AVF NEEDLE Jms North America Corp. | FIE |
| Mar 20, 2003 | K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS Fresenius Medical Care | FIE |
| Jan 7, 2002 | K013384 | SHARGHP A.V. FISTULA NEEDLE SET Shargh Pharmaceutical Co., Inc. | FIE |
| Dec 7, 2001 | K013037 | EXCEL A.V FISUTAL NEEDLE SET Exelint Intl. Co. | FIE |
| Sep 6, 2001 | K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE Jms Co., Ltd., JP | FIE |
| May 4, 2001 | K003123 | RENAX A.V. FISTULA NEEDLE SETS Sunder Biomedical Tech. Co., Ltd., TW | FIE |
| Nov 21, 2000 | K002813 | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp. | FIE |
| Aug 1, 2000 | K001496 | A.V. FISTULA NEEDLE Exelint International, Co. | FIE |
| Apr 10, 2000 | K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET Jms Co., Ltd., JP | FIE |
| Apr 10, 2000 | K000843 | MODIFICATION TO JMS APHERESIS NEEDLE Jms Co., Ltd., JP | FIE |
| Jan 6, 2000 | K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS Medisystems Corp. | FIE |
| Dec 17, 1999 | K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET Bioteque Corp. | FIE |
| Oct 27, 1999 | K992653 | SHELLY PROTECTED AV FISTULA NEEDLE Diasol, Inc. | FIE |
| Aug 30, 1999 | K990510 | JMS APHERESIS NEEDLE Jms Co., Ltd., JP | FIE |
| Aug 30, 1999 | K990470 | JMS A. V. FISTULA NEEDLE SET Jms Co., Ltd., JP | FIE |
| Aug 9, 1999 | K991623 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA Nipro Medical Corp. | FIE |
| Mar 30, 1998 | K974902 | JMS APHERESIS NEEDLE Jms Co., Ltd., JP | FIE |
| Aug 7, 1997 | K970962 | JMS AV FISTULA NEEDLE Jms Co., Ltd., JP | FIE |
| Jun 4, 1996 | K955182 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE Nissho Corp. | FIE |
| Oct 6, 1995 | K945850 | BRAUN DIACAN(R) FISTULA NEEDLES B. Braun of America, Inc. | FIE |
| Feb 18, 1994 | K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD Medisystems Corp. | FIE |
| Mar 2, 1993 | K915174 | JMS APHERESIS NEEDLE Jms Co., Ltd., JP | FIE |
| Apr 20, 1992 | K903440 | VIVAMED FISTULA NEEDLE S.S. Ent. | FIE |
| Aug 28, 1991 | K911199 | JMS AV FISTULA NEEDLES Jms Co., Ltd., JP | FIE |
| Jun 20, 1991 | K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET Medisystems Corp. | FIE |
| Mar 1, 1991 | K902564 | NEEDLE, DIALYSIS Gainor Medical Europe, Ltd. | FIE |
| Nov 20, 1990 | K903945 | EXEL A-V FISTULA SET Exel Intl. | FIE |
| Jan 31, 1990 | K900125 | ARTERIOVENOUS FISTULA SETS Baxter Healthcare Corp | FIE |
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