Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer
FDA 510(k) K883589 · Gambro, Inc.
510(k) numberK883589
Submission
- Device name
- Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer
- Applicant
- Gambro, Inc.
Lincolnshire, IL, US - Received
- August 22, 1988
- Decision date
- September 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
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| K070643 | Phoenix Hemodialysis Delivery System, Version 3.35KDI · Traditional | 11/02/2007SE |
| K032431 | Prisma M60/M100 SetsKDI · Special | 09/15/2003SE |
| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
| K896757 | Gambro AK-10 Dialysis System for High FlowsFKP · Traditional | 08/30/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
| K890112 | Engstrom Eliza + CO2 AnalyzerCCK · Traditional | 03/15/1989SE |
Questions and answers
When was Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer cleared by the FDA?
Gambro Alwall Gfe 12 & 18 Hollow Fiber Dialyzer (K883589) received a 510(k) decision of Substantially Equivalent on September 29, 1988, 38 days after the submission was received.
What is the product code of K883589?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.