Peri-Bottle
FDA 510(k) K902830 · Orion Life Systems, Inc.
510(k) numberK902830
Submission
- Device name
- Peri-Bottle
- Applicant
- Orion Life Systems, Inc.
Wheeling, IL, US - Received
- June 28, 1990
- Decision date
- August 6, 1990
- 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 |
| 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 |
| 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 |
|---|---|---|
| K943835 | Pre-Filled Syringe W/Sterile .25% Acetc AcidKNY · Traditional | 01/24/1995SE |
| K943836 | Pre-Filled 10CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943834 | Sterile .9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943832 | Sterile .9% Sodium Chloride for IrrationJOL · Traditional | 11/21/1994SE |
| K943831 | Pre-Filled 30CC Inflation Syringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943830 | Pre-Filled Syringe W/Sterile 0.9% Sodium Chloride SolutionJOL · Traditional | 11/21/1994SE |
| K943829 | Pre-Filled Sysringe W/Sterile WaterJOL · Traditional | 11/21/1994SE |
| K943828 | Sterile Water for IrrigationJOL · Traditional | 11/21/1994SE |
| K943833 | Sterile Water for IrrationJOL · Traditional | 11/01/1994SE |
| K923168 | Dual Port Enteral Y-AdaptorKNT · Traditional | 06/17/1994SE |
Questions and answers
When was Peri-Bottle cleared by the FDA?
Peri-Bottle (K902830) received a 510(k) decision of Substantially Equivalent on August 6, 1990, 39 days after the submission was received.
What is the product code of K902830?
The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.