Percutaneous Nephrostomy Sets (Schuller)
FDA 510(k) K854911 · Angiomed U.S., Inc.
510(k) numberK854911
Submission
- Device name
- Percutaneous Nephrostomy Sets (Schuller)
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- December 9, 1985
- Decision date
- January 24, 1986
- 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 |
| 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 |
| K781526 | Silastic U-Tube KitGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 09/20/1978SE |
More from Dow Corning Corp. Healthcare Industries Materials
| 510(k) | Device | Decision |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | 09/23/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
Questions and answers
When was Percutaneous Nephrostomy Sets (Schuller) cleared by the FDA?
Percutaneous Nephrostomy Sets (Schuller) (K854911) received a 510(k) decision of Substantially Equivalent on January 24, 1986, 46 days after the submission was received.
What is the product code of K854911?
The FDA product code is GBO – Catheter, Nephrostomy, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.