510(k) DEN130036
- Device
- PROSTATE IMMOBILIZER RECTAL BALLOON
- Applicant
- Radiadyne
- 510(k) number
- DEN130036
- Product code
- PCT
- Decision
- Unknown (DENG)
- Decision date
- 2014-01-28
- Date received
- 2013-07-15
- Regulation
- 892.5720
- Classification name
- Prostate Immobilizer Rectal Balloon
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARK A HELLER
- Address
- 901 New York Ave., NW Washington DC US 20001 20001
FDA Registration Numbers#
- 1000523114
- 3008513105
- 3014246639
- 3007963782
- 3006948745
- 3040865950
- 3015431711
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PCT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023-02-10 |
| K180478 | RectalPro 75 Endorectal Balloon | Qlrad International , Ltd. | 2018-11-13 |
| K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical, LLC | 2015-03-31 |
| K141958 | ERB ENDORECTAL BALLOON | Edge Medical, LLC | 2014-11-18 |