PONClass II
Catheter, Balloon, Dilation Of Cervical Canal
21 CFR 884.4260 / Obstetrics/Gynecology
PON is the FDA product code for Catheter, Balloon, Dilation Of Cervical Canal, a class II device type, regulated under 21 CFR 884.4260. FDA's definition for this code reads: "Mechanical dilation and softening of the cervix". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PON
- Device name
- Catheter, Balloon, Dilation Of Cervical Canal
- FDA definition
- Mechanical dilation and softening of the cervix.
- Regulation
- 21 CFR 884.4260
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code PON
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code PON| Applicant | Clearances |
|---|---|
| Gtimd, LLC | 3 |
| Crossbay Medical | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PON.
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