IOGYN SYSTEM
FDA 510(k) clearance K141848 · decided 2014-08-29
Clearance details
- K-number
- K141848
- Device name
- IOGYN SYSTEM
- Applicant
- Iogyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-09
- Decision date
- 2014-08-29
- Days to decision
- 51 days
- Clearance type
- Special
- Product code
- PGT
- Device class
- 2
- Regulation number
- 884.1710
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cupertino, 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 |
|---|---|---|
| Symphion Operative Hysteroscopy System (K233710) | Minerva Surgical, Inc. | 2024-01-17 |
| IOGYN SYSTEM (DEN130040) | Iogyn, Inc. | 2014-03-28 |
Recalls involving this device
No recalls on record reference this clearance.