Pessary Flexible Silicone Donut Ring
FDA 510(k) K920747 · Bioteque America, Inc.
510(k) numberK920747
Submission
- Device name
- Pessary Flexible Silicone Donut Ring
- Applicant
- Bioteque America, Inc.
Langhorne, PA, US - Received
- February 19, 1992
- Decision date
- August 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K041094 | HSG Catheter SetLKF · Traditional | 06/17/2004SE |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | 05/24/2002SE |
| K013289 | Bioteque Vaginal PessariesHHW · Traditional | 12/27/2001SE |
| K003380 | Bioteque Vaginal DilatorHDX · Traditional | 01/29/2001SE |
| K920633 | Pessary Flexible Silicone NicholsKXP · Traditional | 11/08/1995SE |
| K933628 | Cytology BrushHHT · Traditional | 03/11/1994SE |
| K933521 | SpeculumHIB · Traditional | 03/07/1994SE |
| K920187 | Flexible Silicone GelihornHHW · Traditional | 10/23/1992SE |
| K920177 | Versa-VialDQF · Traditional | 07/13/1992SE |
Questions and answers
When was Pessary Flexible Silicone Donut Ring cleared by the FDA?
Pessary Flexible Silicone Donut Ring (K920747) received a 510(k) decision of Substantially Equivalent on August 29, 1994, 922 days after the submission was received.
What is the product code of K920747?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.