Definition: Cervical Softening And Dilation
| Device Type ID | 4083 |
| Device Name | Dilator, Cervical, Synthetic, Osmotic |
| Physical State | Small Mass Of Synthetic Material |
| Technical Method | When Placed In The Cervical Canal, The Device Absorbs Moisture, Swells, And Exerts Radial Pressure On The Surrounding Structures, Resulting In Mechanical Dilation And Promotion Of Cervical Ripening. |
| 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 | PKN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4083 |
| Device | Dilator, Cervical, Synthetic, Osmotic |
| Product Code | PKN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| CFR Regulation Number | 884.4260 [🔎] |