Panpac Disposable Pessary Fitting Set
FDA 510(k) K153422 · Panpac Medical Corporation
510(k) numberK153422
Submission
- Device name
- Panpac Disposable Pessary Fitting Set
- Applicant
- Panpac Medical Corporation
Shi-Chih Dist., TW - Received
- November 25, 2015
- Decision date
- July 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
More from Panpac Medical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | 01/13/2017SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | 06/04/2014SE |
| K130087 | Panpac Word/Bartholin CatheterKNA · Traditional | 01/10/2014SE |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | 08/08/2013SE |
| K102898 | Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography…LKF · Traditional | 12/15/2011SE |
| K092982 | The Panpac Suction CuretteHHK · Traditional | 07/26/2010SE |
| K092981 | Panpac Vaginal PessaryHHW · Traditional | 07/22/2010SE |
| K092983 | Panpac HSG Catheter SetLKF · Traditional | 06/07/2010SE |
| K092984 | Panpac Uterine Inector, Model UI-4.0, UI-2.0LKF · Traditional | 04/07/2010SE |
Questions and answers
When was Panpac Disposable Pessary Fitting Set cleared by the FDA?
Panpac Disposable Pessary Fitting Set (K153422) received a 510(k) decision of Substantially Equivalent on July 14, 2016, 232 days after the submission was received.
What is the product code of K153422?
The FDA product code is HHW – Pessary, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3575.