Symphion Operative Hysteroscopy System
FDA 510(k) clearance K233710 · decided 2024-01-17
Clearance details
- K-number
- K233710
- Device name
- Symphion Operative Hysteroscopy System
- Applicant
- Minerva Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-20
- Decision date
- 2024-01-17
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- PGT
- Device class
- 2
- Regulation number
- 884.1710
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Santa Clara, 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 |
|---|---|---|
| IOGYN SYSTEM (K141848) | Iogyn, Inc. | 2014-08-29 |
| IOGYN SYSTEM (DEN130040) | Iogyn, Inc. | 2014-03-28 |
Recalls involving this device
No recalls on record reference this clearance.