PANPAC VAGINAL DILATORS
FDA 510(k) clearance K130273 · decided 2013-08-08
Clearance details
- K-number
- K130273
- Device name
- PANPAC VAGINAL DILATORS
- Applicant
- Panpac Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2013-02-04
- Decision date
- 2013-08-08
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- HDX
- Device class
- 2
- Regulation number
- 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shi-Chib District, Taipei Hsien, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Panpac Medical Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| NEO-VAGINA SURGERY SET AND ACCESSORIES (K071754) | KARL STORZ Endoscopy-America, Inc. | 2009-01-07 |
| BIOTEQUE VAGINAL DILATOR (K003380) | Bioteque America, Inc. | 2001-01-29 |
Recalls involving this device
No recalls on record reference this clearance.