Gent-L-Kare Vaginal Irrigation Set
FDA 510(k) K881216 · Geneva Laboratories, Inc.
510(k) numberK881216
Submission
- Device name
- Gent-L-Kare Vaginal Irrigation Set
- Applicant
- Geneva Laboratories, Inc.
Elkhorn, WI, US - Received
- March 22, 1988
- Decision date
- June 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HED – Douche Apparatus, Vaginal, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080200 | Water Works Douching DeviceHED · Traditional | Abbott Research Group, Inc. | 07/10/2008SE |
| K030056 | Worry-Remover IrrigatorHED · Traditional | Corisen Group, Ltd. | 04/22/2003SE |
| K000736 | La JoieHED · Traditional | Goomi Ehwa, Inc. | 08/08/2000SE |
| K902830 | Peri-BottleHED · Traditional | Orion Life Systems, Inc. | 08/06/1990SE |
| K854595 | P.A. Medical Vaginal Irrigation Set #1130HED · Traditional | Pa Medical Corp. | 01/13/1986SE |
| K841710 | Mac Lee Vaginal IrrigatorHED · Traditional | Mac Lee Medical Products | 06/19/1984SE |
| K831667 | Feminine Hygiene DeviceHED · Traditional | Snow Willow Co. | 09/12/1983SE |
| K800956 | Douch Tray-Disposable Vaginal Tray W/BenHED · Traditional | The Healthcare Group Laboratories, Inc. | 10/03/1980SE |
| K800954 | Douche Tray-Dispos. Vaginal Tray W/PovidHED · Traditional | The Healthcare Group Laboratories, Inc. | 10/03/1980SE |
| K800957 | Douche UNIT-1500 ML Disp. ContainerHED · Traditional | The Healthcare Group Laboratories, Inc. | 07/14/1980SE |
More from The Healthcare Group Laboratories, Inc.
| 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 |
| 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 |
Questions and answers
When was Gent-L-Kare Vaginal Irrigation Set cleared by the FDA?
Gent-L-Kare Vaginal Irrigation Set (K881216) received a 510(k) decision of Substantially Equivalent on June 7, 1988, 77 days after the submission was received.
What is the product code of K881216?
The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.