Inglat-O-Ball
FDA 510(k) K904774 · Milex Products, Inc.
510(k) numberK904774
Submission
- Device name
- Inglat-O-Ball
- Applicant
- Milex Products, Inc.
Chicago, IL, US - Received
- October 22, 1990
- Decision date
- December 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHW – Pessary, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3575
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support…HHW · Traditional | Cooper Surgical | 01/20/2026SE |
| K250438 | CooperSurgical Milex® PessariesHHW · Traditional | CooperSurgical, Inc. | 04/11/2025SE |
| K240798 | Cntrl+ Bladder Support PessaryHHW · Traditional | Cntrl+, Inc. | 12/17/2024SE |
| K232677 | Reia pessaryHHW · Traditional | Reia, LLC | 05/21/2024SE |
| K232525 | Yoni.Fit Bladder SupportHHW · Traditional | Watkins-Conti Products, Inc. | 05/17/2024SE |
| K233548 | Uresta®HHW · Traditional | Resilia, Inc. | 04/03/2024SE |
| K231786 | Gynethotics PessaryHHW · Traditional | Cosm Medical | 03/06/2024SE |
| K190277 | ProVate Vaginal SupportHHW · Traditional | Contipi Medical , Ltd. | 07/08/2019SE |
| K183468 | Revive Reusable Bladder SupportHHW · Traditional | Rinovum Subsidiary 2, LLC | 01/25/2019SE |
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | Panpac Medical Corporation | 10/31/2018SE |
More from Panpac Medical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K001545 | Pipet CuretHHK · Special | 06/15/2000SE |
| K904026 | Inflat-O-BallHHW · Traditional | 10/10/1990SE |
| K900903 | Kopans Hookwire Lesion Localization NeedleGDF · Traditional | 05/03/1990SE |
| K882628 | Endo C BrushHHT · Traditional | 07/25/1988SE |
| K862410 | Milex Kegel Perineal ExerciserHIR · Traditional | 07/31/1986SE |
| K861385 | Milex Bartholin Gland CatheterKNA · Traditional | 06/16/1986SE |
| K760264 | Curette, Proposed Tis-U-Trap, MetalHHK · Traditional | 10/06/1976SE |
Questions and answers
When was Inglat-O-Ball cleared by the FDA?
Inglat-O-Ball (K904774) received a 510(k) decision of Substantially Equivalent on December 7, 1990, 46 days after the submission was received.
What is the product code of K904774?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.