HyaloGYN Vaginal Hydrating Gel
FDA 510(k) clearance K150883 · decided 2015-09-01
Clearance details
- K-number
- K150883
- Device name
- HyaloGYN Vaginal Hydrating Gel
- Applicant
- Fidia Farmaceutici S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-02
- Decision date
- 2015-09-01
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Abano Terme, IT
- 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HYALGAN® (P950027/S019) | Fidia Farmaceutici S.P.A. | 2024-06-28 |
| TRILURON® (P180040/S005) | Fidia Farmaceutici S.P.A. | 2024-06-28 |
| TRILURON® (sodium hyaluronate) (P180040/S004) | Fidia Farmaceutici S.P.A. | 2023-01-19 |
| HYALGAN® (sodium hyaluronate) (P950027/S018) | Fidia Farmaceutici S.P.A. | 2023-01-19 |
| HYALGAN® (P950027/S017) | Fidia Farmaceutici S.P.A. | 2022-10-04 |
| TRILURON® (P180040/S003) | Fidia Farmaceutici S.P.A. | 2022-10-04 |
| TRILURON® (P180040/S002) | Fidia Farmaceutici S.P.A. | 2022-08-08 |
| HYALGAN® (P950027/S016) | Fidia Farmaceutici S.P.A. | 2022-08-08 |