Pro-Tx Endorectal Balloon (PROT-25)
FDA 510(k) clearance K223249 · decided 2023-02-10
Clearance details
- K-number
- K223249
- Device name
- Pro-Tx Endorectal Balloon (PROT-25)
- Applicant
- Dxtx Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-12
- Decision date
- 2023-02-10
- Days to decision
- 151 days
- Clearance type
- Abbreviated
- Product code
- PCT
- Device class
- 2
- Regulation number
- 892.5720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RectalPro 75 Endorectal Balloon (K180478) | Qlrad International , Ltd. | 2018-11-13 |
| Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (K150234) | Myriad Medical, LLC | 2015-03-31 |
| ERB ENDORECTAL BALLOON (K141958) | Edge Medical, LLC | 2014-11-18 |
| PROSTATE IMMOBILIZER RECTAL BALLOON (DEN130036) | Radiadyne | 2014-01-28 |
Recalls involving this device
No recalls on record reference this clearance.