Panpac Vaginal Dilators
FDA 510(k) K130273 · Panpac Medical Corporation
510(k) numberK130273
Submission
- Device name
- Panpac Vaginal Dilators
- Applicant
- Panpac Medical Corporation
Shi-Chib District, Taipei Hsien, TW - Received
- February 4, 2013
- Decision date
- August 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HDX – Dilator, Vaginal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.3900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal DilatorsHDX · Traditional | Plus EV Holdings Dba Intimate Rose | 08/14/2024SE |
| K233689 | Hope&Her Vaginal DilatorsHDX · Traditional | Lujena, Inc. | 05/02/2024SE |
| K222492 | Hope&Her Vaginal DilatorsHDX · Traditional | Lujena, Inc. | 06/27/2023SE |
| K231430 | Intimate Rose Vaginal DilatorsHDX · Traditional | Plus EV Holdings Dba Intimate Rose | 06/07/2023SE |
| K220035 | Milli Vaginal DilatorHDX · Traditional | Materna Medical | 02/27/2023SE |
| K211959 | Milli Vaginal DilatorHDX · Traditional | Materna Medical | 12/01/2021SE |
| K071754 | Neo-Vagina Surgery Set and AccessoriesHDX · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/07/2009SE |
| K003380 | Bioteque Vaginal DilatorHDX · Traditional | Bioteque America, Inc. | 01/29/2001SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | 01/13/2017SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | 07/14/2016SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | 06/04/2014SE |
| K130087 | Panpac Word/Bartholin CatheterKNA · Traditional | 01/10/2014SE |
| 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 Vaginal Dilators cleared by the FDA?
Panpac Vaginal Dilators (K130273) received a 510(k) decision of Substantially Equivalent on August 8, 2013, 185 days after the submission was received.
What is the product code of K130273?
The FDA product code is HDX – Dilator, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.