Aqueduct 100 Cervical Dilator
FDA 510(k) clearance K160664 · decided 2016-08-01
Clearance details
- K-number
- K160664
- Device name
- Aqueduct 100 Cervical Dilator
- Applicant
- Gtimd, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-03-09
- Decision date
- 2016-08-01
- Days to decision
- 145 days
- Clearance type
- Abbreviated
- Product code
- PON
- Device class
- 2
- Regulation number
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Amherst, NH, 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 |
|---|---|---|
| Aqueduct 200 Cervical Dilation Balloon Catheter (K202433) | Gtimd, LLC | 2021-10-15 |
| Aqueduct 100 Plus Cervical Dilation Balloon Catheter (K202427) | Gtimd, LLC | 2020-11-06 |
| CrossBay Cervical Dilator Catheter System (K190813) | Crossbay Medical | 2019-08-23 |
Recalls involving this device
No recalls on record reference this clearance.