Product code FFA
- Device name
- Tube, Drainage, Suprapubic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5090
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00792293995100 | Uro-Kit® Reusable Latex Leg Bag System 10 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985323 | Uro-Kit® Reusable Latex Leg Bag System 32 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985262 | Uro-Kit® Reusable Latex Leg Bag System 26 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985187 | Uro-Kit® Reusable Latex Leg Bag System 18 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985163 | Uro-Kit® Reusable Latex Leg Bag System 16 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985095 | Uro-Kit® Reusable Latex Leg Bag System 9 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293985101 | Uro-Kit® Reusable Latex Leg Bag System 10 oz. | UROCARE PRODUCTS, INC. | 2018-04-10 |
| 00792293995445 | Uro-Kit® Reusable Latex Leg Bag System 44 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995322 | Uro-Kit® Reusable Latex Leg Bag System 32 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995261 | Uro-Kit® Reusable Latex Leg Bag System 26 oz. | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 00792293995162 | Uro-Kit® Reusable Latex Leg Bag System 16 oz. (500 mL.) | UROCARE PRODUCTS, INC. | 2018-04-09 |
| 04026704419036 | TAUT | TELEFLEX INCORPORATED | 2016-09-16 |
| 04026704419029 | TAUT | TELEFLEX INCORPORATED | 2016-09-16 |
| 04026704419012 | TAUT | TELEFLEX INCORPORATED | 2016-09-16 |
| 04026704419005 | TAUT | TELEFLEX INCORPORATED | 2016-09-16 |
| 04026704418992 | TAUT | TELEFLEX INCORPORATED | 2016-09-16 |
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| 08714729137665 | vanSonnenberg™ Sump | BOSTON SCIENTIFIC CORPORATION | 2016-08-05 |
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| 08714729297741 | Stretch™ VL | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729297734 | Stretch™ VL | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |