NEO-VAGINA SURGERY SET AND ACCESSORIES
FDA 510(k) clearance K071754 · decided 2009-01-07
Clearance details
- K-number
- K071754
- Device name
- NEO-VAGINA SURGERY SET AND ACCESSORIES
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-28
- Decision date
- 2009-01-07
- Days to decision
- 559 days
- Clearance type
- Traditional
- Product code
- HDX
- Device class
- 2
- Regulation number
- 884.3900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Culver City, CA, 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 |
| BIOTEQUE VAGINAL DILATOR (K003380) | Bioteque America, Inc. | 2001-01-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |