HYDROSIL; MAGIC; PERSONAL CATHETER
FDA 510(k) clearance K122785 · decided 2013-05-14
Clearance details
- K-number
- K122785
- Device name
- HYDROSIL; MAGIC; PERSONAL CATHETER
- Applicant
- Rochester Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-09-11
- Decision date
- 2013-05-14
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- EZD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stewartville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter recall (Z-1307-2018) | C.R. Bard, Inc. | 2018-04-04 |
| Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged recall (Z-1308-2018) | C.R. Bard, Inc. | 2018-04-04 |
| Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter recall (Z-1309-2018) | C.R. Bard, Inc. | 2018-04-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMSOFT URETHRAL INSERT (P990002/S002) | Rochester Medical Corp. | 2013-03-21 |
| FEMSOFT URETHRAL INSERT (P990002/S001) | Rochester Medical Corp. | 2000-12-28 |
| FEMSOFT URETHRAL INSERT (P990002) | Rochester Medical Corp. | 1999-09-30 |