RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
FDA 510(k) clearance K962472 · decided 1996-08-27
Clearance details
- K-number
- K962472
- Device name
- RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-25
- Decision date
- 1996-08-27
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FAP
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon recall (Z-1368-2018) | Teleflex Medical Europe Ltd | 2018-04-12 |