Geneva Laboratories, Inc.
Medical device manufacturer in Elkhorn, WI.
13510(k) clearances
0PMA approvals
0recalls
Device types
- FPA Set, Administration, Intravascular 2
- KNX Collector, Urine, (And Accessories) For… 2
- KSB Set, Transfer (Blood/Plasma) 1
- MMK Container, Sharps 1
- HIB Speculum, Vaginal, Nonmetal 1
- KDD Kit, Surgical Instrument, Disposable 1
- EFQ Gauze/Sponge, Internal 1
- HED Douche Apparatus, Vaginal, Therapeutic 1
- FCE Enema Kit 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K881217 | Gent-L-Kare Sterile Urinary Leg BagKNX · Traditional | 07/29/1988SE |
| K881218 | Gent-L-Kare Cleansing Enema SetFCE · Traditional | 07/28/1988SE |
| K881213 | Gent-L-Kare Sterile Urinary Drainage Bag CenterKNX · Traditional | 07/28/1988SE |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | 06/07/1988SE |
| K861308 | Accupac Custom Pack Kerlix SquaresEFQ · Traditional | 05/02/1986SE |
| K861219 | Accupac Custom Skin Scrub Kit · Traditional | 04/15/1986SE |
| K853265 | Accupac Custom Operating Room PROCEDURE-DK876543 · Traditional | 08/26/1985SE |
| K843206 | Cook County Hospital Dressing Change SetKDD · Traditional | 05/24/1985SE |
| K844255 | Gent-L-Kare Sterile I.V. Start KitFPA · Traditional | 12/19/1984SE |
| K843090 | University of Chicago Vascular AngiogramFPA · Traditional | 12/04/1984SE |
| K830725 | Gent-L-Spec Dispos. Vaginal SpeculumHIB · Traditional | 04/27/1983SE |
| K822735 | Sure-Count Disposable Needle CounterMMK · Traditional | 03/09/1983SE |
| K802940 | Super-Spike Transfer SetKSB · Traditional | 01/15/1981SE |