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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2013 | Medisystems a NX Stage Company Medisystems 17 Gauge x 1" inch AV Fistula Needle
Product Code: D9-2007MGLB
Product Usage:
Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device Terminated |
FIE | K910734 |
| Jan 24, 2013 | Medisystems a NX Stage Company Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set
Product Code: BH-2035PE
Product Usage:
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis pro Terminated |
FIE | K990803 |
| Feb 29, 2012 | Medisystems Corp Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1"
Ref. Number: D9-2007MG.
Medisystems AVF with MasterGuard anti-stick needle prote Terminated |
FIE | K910734 |
| Jun 17, 2005 | HK Surgical Inc Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15. Terminated |
FIE | None listed |
| Jun 17, 2005 | HK Surgical Inc Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8 Terminated |
FIE | None listed |
| Jun 17, 2005 | HK Surgical Inc Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6 Terminated |
FIE | None listed |
| May 21, 2003 | Nipro Corp The following brand name labeled products are under recall (all
catalog numbers and all lot numbers under recall):
NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula
Set and EXEL Secure Terminated |
FIE | K002813 |
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