Mac Lee Vaginal Irrigator
FDA 510(k) K841710 · Mac Lee Medical Products
510(k) numberK841710
Submission
- Device name
- Mac Lee Vaginal Irrigator
- Applicant
- Mac Lee Medical Products
Mchenry, IL, US - Received
- April 24, 1984
- Decision date
- June 19, 1984
- 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 |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | Geneva Laboratories, Inc. | 06/07/1988SE |
| K854595 | P.A. Medical Vaginal Irrigation Set #1130HED · Traditional | Pa Medical Corp. | 01/13/1986SE |
| 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 |
|---|---|---|
| K872953 | Disposable I.V. Administration SetFPA · Traditional | 01/06/1988SE |
| K872006 | Disposable Barium Enema Tip with Retention CuffFGD · Traditional | 11/17/1987SE |
| K870995 | Scalp Vein SetFPA · Traditional | 07/31/1987SE |
| K864781 | Maclee/Boin Medica Sterile Needle/Syringe 20ML/CCFMF · Traditional | 12/29/1986SE |
| K864779 | Maclee/Boin Medica Sterile Needle/Syringe 50ML/CCFMF · Traditional | 12/29/1986SE |
| K864778 | Maclee/Boin Medica Sterile Needle/Syringe 30ML/CCFMF · Traditional | 12/29/1986SE |
| K864777 | Maclee/Boin Medica Sterile Needle & Syringe 3ML/CCFMF · Traditional | 12/29/1986SE |
| K864783 | Maclee/Boin Medica Sterile Needle & Syringe 5ML/CCFMF · Traditional | 12/23/1986SE |
| K864782 | Maclee/Boin Medica Sterile Needle/Syringe 10ML/CCFMF · Traditional | 12/23/1986SE |
| K864780 | Maclee/Boin Medica Sterile Needle & Syringe 1ML/CCFMF · Traditional | 12/23/1986SE |
Questions and answers
When was Mac Lee Vaginal Irrigator cleared by the FDA?
Mac Lee Vaginal Irrigator (K841710) received a 510(k) decision of Substantially Equivalent on June 19, 1984, 56 days after the submission was received.
What is the product code of K841710?
The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.