Bioteque Vaginal Dilator
FDA 510(k) K003380 · Bioteque America, Inc.
510(k) numberK003380
Submission
- Device name
- Bioteque Vaginal Dilator
- Applicant
- Bioteque America, Inc.
Langhorne, PA, US - Received
- October 31, 2000
- Decision date
- January 29, 2001
- 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 |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | Panpac Medical Corporation | 08/08/2013SE |
| K071754 | Neo-Vagina Surgery Set and AccessoriesHDX · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/07/2009SE |
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| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | 05/24/2002SE |
| K013289 | Bioteque Vaginal PessariesHHW · Traditional | 12/27/2001SE |
| K920633 | Pessary Flexible Silicone NicholsKXP · Traditional | 11/08/1995SE |
| K920747 | Pessary Flexible Silicone Donut RingHHW · Traditional | 08/29/1994SE |
| 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 Bioteque Vaginal Dilator cleared by the FDA?
Bioteque Vaginal Dilator (K003380) received a 510(k) decision of Substantially Equivalent on January 29, 2001, 90 days after the submission was received.
What is the product code of K003380?
The FDA product code is HDX – Dilator, Vaginal, a Class II (moderate risk) device regulated under 21 CFR 884.3900.