Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
FDA 510(k) clearance K150234 · decided 2015-03-31
Clearance details
- K-number
- K150234
- Device name
- Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
- Applicant
- Myriad Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-02-02
- Decision date
- 2015-03-31
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- PCT
- Device class
- 2
- Regulation number
- 892.5720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tampa, FL, 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 |
|---|---|---|
| Pro-Tx Endorectal Balloon (PROT-25) (K223249) | Dxtx Medical, Inc. | 2023-02-10 |
| RectalPro 75 Endorectal Balloon (K180478) | Qlrad International , Ltd. | 2018-11-13 |
| 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.