PERCUTANEOUS NEPHROSTOMY SET
FDA 510(k) clearance K820867 · decided 1982-04-13
Clearance details
- K-number
- K820867
- Device name
- PERCUTANEOUS NEPHROSTOMY SET
- Applicant
- Van-Tec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-29
- Decision date
- 1982-04-13
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GBO
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY (K041995) | Uresil, LLC | 2004-08-19 |
| GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C (K021632) | Uresil, L.P. | 2002-06-13 |
| URESIL GENERAL PURPOSE DRAINAGE CATHETER (K912109) | Uresil Corp. | 1991-08-12 |
| PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (K854911) | Angiomed U.S., Inc. | 1986-01-24 |
| PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (K854909) | Angiomed U.S., Inc. | 1986-01-24 |
| PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (K854905) | Angiomed U.S., Inc. | 1986-01-24 |
| PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (K854906) | Angiomed U.S., Inc. | 1986-01-24 |
| PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (K854907) | Angiomed U.S., Inc. | 1986-01-24 |
| SILASTIC NEPHROSTOMY SYSTEM (K781664) | Dow Corning Corp. Healthcare Industries Materials | 1979-01-22 |
| SILASTIC U-TUBE KIT (K781526) | Dow Corning Corp. Healthcare Industries Materials | 1978-09-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1339-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN # De recall (Z-1345-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1346-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter wi recall (Z-1106-04) | Boston Scientific Corp | 2004-07-20 |