FDA Product Code
FDA Product Code PCT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5720
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023-02-10 | Abbreviated | PDF ↗ |
| K180478 | RectalPro 75 Endorectal Balloon | Qlrad International , Ltd. | 2018-11-13 | Traditional | PDF ↗ |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical, LLC | 2015-03-31 | Traditional | PDF ↗ |
| K141958 | ERB ENDORECTAL BALLOON | Edge Medical, LLC | 2014-11-18 | Traditional | PDF ↗ |
| DEN130036 | PROSTATE IMMOBILIZER RECTAL BALLOON | Radiadyne | 2014-01-28 | Direct | — |
Product code PCT · Class II · Radiology. Data: openFDA.