Silastic U-Tube Kit
FDA 510(k) K781526 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK781526
Submission
- Device name
- Silastic U-Tube Kit
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Mchenry, IL, US - Received
- September 5, 1978
- Decision date
- September 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBO – Catheter, Nephrostomy, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | Uresil, LLC | 08/19/2004SE |
| K021632 | GP General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking…GBO · Special | Uresil, L.P. | 06/13/2002SE |
| K912109 | Uresil General Purpose Drainage CatheterGBO · Traditional | Uresil Corp. | 08/12/1991SE |
| K854911 | Percutaneous Nephrostomy Sets (Schuller)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854909 | Pediatric Percutaneous Nephrostomy SetsGBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854907 | Percutaneous Nephrostomy Sets (Gunther)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854906 | Percutaneous Nephrostomy Sets (Otto)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854905 | Percutaneous Nephrostomy Sets (Loop Technique)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K820867 | Percutaneous Nephrostomy SetGBO · Traditional | Van-Tec, Inc. | 04/13/1982SE |
| K781664 | Silastic Nephrostomy SystemGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 01/22/1979SE |
More from Dow Corning Corp. Healthcare Industries Materials
| 510(k) | Device | Decision |
|---|---|---|
| K853186 | Silastic Inflatable Bone Plug H.P.LZN · Traditional | 09/24/1985SE |
| K844637 | Whiteside Acrylic Cement Spacer SleeveLTC · Traditional | 06/19/1985SE |
| K850255 | Dow Corning Wright Titanium Wrist Joint Grommet · Traditional | 05/01/1985SE |
| K843995 | Tf-Ii Hip ProsthesisKWL · Traditional | 04/23/1985SE |
| K842559 | Whiteside Ortholoc Total Hip FemoralKWL · Traditional | 12/20/1984SE |
| K840357 | Ssa Hip ProsthesisJDI · Traditional | 02/17/1984SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | 07/10/1981SE |
Questions and answers
When was Silastic U-Tube Kit cleared by the FDA?
Silastic U-Tube Kit (K781526) received a 510(k) decision of Substantially Equivalent on September 20, 1978, 15 days after the submission was received.
What is the product code of K781526?
The FDA product code is GBO – Catheter, Nephrostomy, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.