FDA Product Code
FDA Product Code FIE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5540
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC | 2026-08-06 | Traditional | PDF ↗ |
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation | 2025-08-15 | Traditional | PDF ↗ |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 | Traditional | PDF ↗ |
| K171505 | Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) | Dimesol, Inc. | 2018-05-17 | Traditional | PDF ↗ |
| K163025 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2017-07-20 | Traditional | PDF ↗ |
| K151017 | JMS Harmony A.V. Fistula Needle Set | JMS North America Corporation | 2015-05-13 | Special | PDF ↗ |
| K131950 | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET | Summit International Medical Technologies, Inc. | 2015-01-16 | Traditional | PDF ↗ |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | JMS North America Corporation | 2014-12-23 | Special | PDF ↗ |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | Nxstage Medical, Inc. | 2014-09-11 | Traditional | PDF ↗ |
| K112734 | APLAN A.V. FISTULA NEEDLE SET | Aplan Well Enterprise Co., Ltd. | 2012-04-24 | Traditional | PDF ↗ |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | JMS North America Corporation | 2011-10-27 | Special | PDF ↗ |
| K111948 | WINGEATER V2 | JMS North America Corporation | 2011-10-24 | Special | PDF ↗ |
| K110157 | SYSLOC MINI V3 | JMS North America Corporation | 2011-02-11 | Special | PDF ↗ |
| K100520 | NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER | Nipro Medical Corporation | 2010-03-17 | Special | PDF ↗ |
| K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 | Jms North America Corp. | 2010-02-09 | Traditional | PDF ↗ |
| K093985 | NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2010-01-22 | Special | PDF ↗ |
| K082882 | A.V. FISTULA BLUNT NEEDLE SET | Jms North America Corp. | 2009-01-21 | Traditional | PDF ↗ |
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | Medisystems Corp. | 2007-02-12 | Traditional | PDF ↗ |
| K063368 | NIPRO BIOHOLE NEEDLE | Nipro Medical Corp. | 2007-02-05 | Traditional | PDF ↗ |
| K063721 | NIPRO SAFETOUCH II GAMMA | Nipro Medical Corp. | 2007-01-12 | Special | PDF ↗ |
| K052267 | SUPERCATH V | Togo Medikit Co., Ltd. | 2006-10-27 | Traditional | PDF ↗ |
| K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET | Jms North America Corp. | 2005-08-04 | Special | PDF ↗ |
| K040247 | PLUME SAFETY AVF NEEDLE | Jms North America Corp. | 2004-03-03 | Special | PDF ↗ |
| K023162 | FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS | Fresenius Medical Care | 2003-03-20 | Traditional | PDF ↗ |
| K013384 | SHARGHP A.V. FISTULA NEEDLE SET | Shargh Pharmaceutical Co., Inc. | 2002-01-07 | Traditional | PDF ↗ |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Exelint Intl. Co. | 2001-12-07 | Traditional | PDF ↗ |
| K002352 | JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE | Jms Co., Ltd. | 2001-09-06 | Traditional | PDF ↗ |
| K003123 | RENAX A.V. FISTULA NEEDLE SETS | Sunder Biomedical Tech. Co., Ltd. | 2001-05-04 | Traditional | PDF ↗ |
| K002813 | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE | Nipro Medical Corp. | 2000-11-21 | Traditional | PDF ↗ |
| K001496 | A.V. FISTULA NEEDLE | Exelint International, Co. | 2000-08-01 | Traditional | PDF ↗ |
| K000843 | MODIFICATION TO JMS APHERESIS NEEDLE | Jms Co., Ltd. | 2000-04-10 | Special | PDF ↗ |
| K000845 | MODIFICATION TO JMS A.V. FISTULA NEEDLE SET | Jms Co., Ltd. | 2000-04-10 | Special | PDF ↗ |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | Medisystems Corp. | 2000-01-06 | Traditional | PDF ↗ |
| K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET | Bioteque Corp. | 1999-12-17 | Traditional | PDF ↗ |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | Diasol, Inc. | 1999-10-27 | Traditional | PDF ↗ |
| K990470 | JMS A. V. FISTULA NEEDLE SET | Jms Co., Ltd. | 1999-08-30 | Traditional | PDF ↗ |
| K990510 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1999-08-30 | Traditional | PDF ↗ |
| K991623 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA | Nipro Medical Corp. | 1999-08-09 | Traditional | PDF ↗ |
| K974902 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1998-03-30 | Traditional | PDF ↗ |
| K970962 | JMS AV FISTULA NEEDLE | Jms Co., Ltd. | 1997-08-07 | Traditional | PDF ↗ |
| K955182 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE | Nissho Corp. | 1996-06-04 | Traditional | PDF ↗ |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | B. Braun of America, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD | Medisystems Corp. | 1994-02-18 | Traditional | PDF ↗ |
| K915174 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1993-03-02 | Traditional | PDF ↗ |
| K903440 | VIVAMED FISTULA NEEDLE | S.S. Ent. | 1992-04-20 | Traditional | PDF ↗ |
| K911199 | JMS AV FISTULA NEEDLES | Jms Co., Ltd. | 1991-08-28 | Traditional | PDF ↗ |
| K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET | Medisystems Corp. | 1991-06-20 | Traditional | PDF ↗ |
| K902564 | NEEDLE, DIALYSIS | Gainor Medical Europe, Ltd. | 1991-03-01 | Traditional | PDF ↗ |
| K903945 | EXEL A-V FISTULA SET | Exel Intl. | 1990-11-20 | Traditional | PDF ↗ |
| K900125 | ARTERIOVENOUS FISTULA SETS | Baxter Healthcare Corp | 1990-01-31 | Traditional | PDF ↗ |
| K891062 | TERUMO AV FISTULA NEEDLE SET | Terumo Medical Corp. | 1989-06-22 | Traditional | PDF ↗ |
| K880726 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | 1988-03-16 | Traditional | PDF ↗ |
| K862002 | MEDISYSTEMS PHERESIS NEEDLE | Medisystems Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K854773 | SUPERCATH A.V. FISTULA | Togo Medikit Co., Ltd. | 1986-04-08 | Traditional | PDF ↗ |
| K860789 | JMD AV FISTULA NEEDLE (MODIFICATION) | Jms Co., Ltd. | 1986-03-18 | Traditional | PDF ↗ |
| K860449 | MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE | Top Corp. | 1986-02-26 | Traditional | PDF ↗ |
| K860241 | JMS AV FISTULA NEEDLE | Jms Co., Ltd. | 1986-02-05 | Traditional | PDF ↗ |
| K854951 | PLUME Y SET | Hospal Medical Corp. | 1986-01-08 | Traditional | PDF ↗ |
| K851453 | HOSPAL FISTULA NEEDLE | Hospal Medical Corp. | 1985-04-29 | Traditional | PDF ↗ |
| K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE | Top Surgical Manufacturers Co. | 1985-01-08 | Traditional | PDF ↗ |
| K832136 | DUAL FLOW NEEDLE | Travenol Laboratories, S.A. | 1983-10-14 | Traditional | PDF ↗ |
| K812621 | DELTA-A.V. FISTULA CANNULATION SET | Amisco Trading Corp. | 1981-09-24 | Traditional | PDF ↗ |
| K811838 | MEDISYSTEMS FISTULA NEEDLE | Medisystems Corp. | 1981-09-08 | Traditional | PDF ↗ |
| K802956 | GAMBRO A-V FISTULA NEEDLE SET | Gambro, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K801966 | HEMO-CATH II KIDNEY DIALYSIS CATHETER | Medical Components, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801618 | ARGYLE A-V MEDI-WING HEMODIALYSIS SET | Sherwood Medical Co. | 1980-08-13 | Traditional | PDF ↗ |
| K801632 | THE BELLCO FISTULA NEEDLES | Bellco Artifidial Organ Spec., Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K791489 | VITAL CATHETER | Hospal Medical Corp. | 1979-10-26 | Traditional | PDF ↗ |
| K791490 | UNIPUNCTURE CATHETER | Hospal Medical Corp. | 1979-10-26 | Traditional | PDF ↗ |
| K782021 | A.V. FISTULA NEEDLE SET | Cordis Corp. | 1979-03-21 | Traditional | PDF ↗ |
| K772362 | AVF SET FOR SINGLE NEEDLE HEMODIALYSIS | Terumo America, Inc. | 1978-03-17 | Traditional | PDF ↗ |
| K771494 | A.V. FISTULA NEEDLE SET (354) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771492 | A.V. FISTULA NEEDLE SET (#351) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771491 | A.V. FISTULA NEEDLE SET (#364) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771493 | A.V. FISTULA NEEDLE SET (#341) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771495 | A.V. FISTULA NEEDLE SET (#361) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771490 | A.V. FISTULA NEEDLE SET (#344) | Sorensen Research | 1977-08-16 | Traditional | PDF ↗ |
| K771206 | AV FISTULA NEEDLE SET | Terumo America, Inc. | 1977-07-15 | Traditional | PDF ↗ |
| K770864 | HEMODIALYSIS FISTULA SET | Venospital, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K770699 | NEEDLE SET, A-V FISTULA | Medical Disposables Intl., Inc. | 1977-06-14 | Traditional | PDF ↗ |
Product code FIE · Class II · Gastroenterology, Urology. Data: openFDA.