Device, Female Incontinence
FDA 510(k) K781863 · Eschmann Bros. & Walsh , Ltd.
510(k) numberK781863
Submission
- Device name
- Device, Female Incontinence
- Applicant
- Eschmann Bros. & Walsh , Ltd.
Walker, MI, US - Received
- November 6, 1978
- Decision date
- November 6, 1978
- Decision
- Unknown (SESP)
- 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
Other 510(k)s with product code HHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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Questions and answers
When was Device, Female Incontinence cleared by the FDA?
Device, Female Incontinence (K781863) received a 510(k) decision of Unknown on November 6, 1978, 0 days after the submission was received.
What is the product code of K781863?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.