SILASTIC NEPHROSTOMY SYSTEM
FDA 510(k) clearance K781664 · decided 1979-01-22
Clearance details
- K-number
- K781664
- Device name
- SILASTIC NEPHROSTOMY SYSTEM
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1978-09-28
- Decision date
- 1979-01-22
- Days to decision
- 116 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
- Mchenry, IL, 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 |
| PERCUTANEOUS NEPHROSTOMY SET (K820867) | Van-Tec, Inc. | 1982-04-13 |
| SILASTIC U-TUBE KIT (K781526) | Dow Corning Corp. Healthcare Industries Materials | 1978-09-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE SOFT RINSE SYSTEM (P800060/S007) | Dow Corning Corp. Healthcare Industries Materials | 1991-03-05 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-18 |
| SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-05 |
| THE SOFT RINSE SYSTEM (P800060/S006) | Dow Corning Corp. Healthcare Industries Materials | 1985-07-30 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008) | Dow Corning Corp. Healthcare Industries Materials | 1984-10-31 |
| THE SOFT RINSE SYSTEM (P800060/S005) | Dow Corning Corp. Healthcare Industries Materials | 1984-04-04 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009) | Dow Corning Corp. Healthcare Industries Materials | 1984-03-12 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004) | Dow Corning Corp. Healthcare Industries Materials | 1983-11-09 |