BIOTEQUE VAGINAL DILATOR
FDA 510(k) clearance K003380 · decided 2001-01-29
Clearance details
- K-number
- K003380
- Device name
- BIOTEQUE VAGINAL DILATOR
- Applicant
- Bioteque America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-31
- Decision date
- 2001-01-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HDX
- Device class
- 2
- Regulation number
- 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Intimate Rose Vaginal Dilators (K241748) | Plus EV Holdings Dba Intimate Rose | 2024-08-14 |
| Hope&Her Vaginal Dilators (K233689) | Lujena, Inc. | 2024-05-02 |
| Hope&Her Vaginal Dilators (K222492) | Lujena, Inc. | 2023-06-27 |
| Intimate Rose Vaginal Dilators (K231430) | Plus EV Holdings Dba Intimate Rose | 2023-06-07 |
| Milli Vaginal Dilator (K220035) | Materna Medical | 2023-02-27 |
| Milli Vaginal Dilator (K211959) | Materna Medical | 2021-12-01 |
| PANPAC VAGINAL DILATORS (K130273) | Panpac Medical Corporation | 2013-08-08 |
| NEO-VAGINA SURGERY SET AND ACCESSORIES (K071754) | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
Recalls involving this device
No recalls on record reference this clearance.