Definition: Mechanical Dilation Of The Cervical Canal For Labor.
| Device Type ID | 4080 |
| Device Name | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Physical State | Catheter With Inflatable Balloon |
| Technical Method | Use Mechanical Force To Dilate Cervix To Prepare For Vaginal Delivery. |
| Target Area | Uterine Cervix |
| 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 | PFJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4080 |
| Device | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Product Code | PFJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hygroscopic Laminaria Cervical Dilator. |
| CFR Regulation Number | 884.4260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
UTAH MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 17 |
Device Operates Differently Than Expected | 7 |
Material Puncture / Hole | 5 |
Material Rupture | 4 |
Insufficient Information | 3 |
Material Perforation | 2 |
Stylet | 1 |
Break | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Material Separation | 1 |
Use Of Device Problem | 1 |
Balloon | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon, Inc. | II | Jan-06-2016 |