MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
FDA 510(k) clearance K041995 · decided 2004-08-19
Clearance details
- K-number
- K041995
- Device name
- MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
- Applicant
- Uresil, LLC
- Decision
- Substantially Equivalent
- Date received
- 2004-07-23
- Decision date
- 2004-08-19
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- GBO
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Skokie, 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 |
|---|---|---|
| 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 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
No recalls on record reference this clearance.