Definition: Mechanical Dilation And Softening Of The Cervix.
| Device Type ID | 4086 |
| Device Name | Catheter, Balloon, Dilation Of Cervical Canal |
| Physical State | Catheter With Inflatable Balloons. |
| Technical Method | When Placed In The Cervical Canal, The Device Uses Mechanical Force To Dilate And Soften The Cervix. |
| Target Area | Cervical Canal |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.4260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PON |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4086 |
| Device | Catheter, Balloon, Dilation Of Cervical Canal |
| Product Code | PON |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| CFR Regulation Number | 884.4260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GTIMD LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |