510(k) K912109
- Device
- URESIL GENERAL PURPOSE DRAINAGE CATHETER
- Applicant
- URESIL CORP.
- 510(k) number
- K912109
- Product code
- GBO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-12
- Date received
- 1991-05-13
- Regulation
- 878.4200
- Classification name
- Catheter, Nephrostomy, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEV MELINYSHYN
- Address
- 5418 W. Touhy Ave. Skokie IL US 60077 60077
FDA Registration Numbers#
- 1000523114
- 1721676
- 3027260597
- 3012480535
- 3013557562
- 3011689956
- 3012649202
- 1450395
- 1825146
- 3003965134
- 3011137372
- 3005580113
- 9710641
- 1625425
- 3014246639
- 9617744
- 9681260
- 3007092328
- 1644312
- 3006131984
- 3005099803
- 1225687
- 1319639
- 3035451914
- 3005987240
- 3007156625
- 3010419931
- 3004859241
- 9610711
- 3015924373
- 3010131137
- 3016678045
- 1828132
- 3030446844
- 3004111573
- 1000121056
- 1319211
- 3010273872
- 1820334
- 3010011359
- 3007695959
- 3005941719
- 3004207966
- 1724474
- 3004134316
- 3007738736
- 1417485
- 3030087693
- 3030733800
- 2124215
- 2183744
- 3004365956
- 3007146453
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY | Uresil, LLC | 2004-08-19 |
| K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C | Uresil, L.P. | 2002-06-13 |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | Angiomed U.S., Inc. | 1986-01-24 |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | Angiomed U.S., Inc. | 1986-01-24 |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | Angiomed U.S., Inc. | 1986-01-24 |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | Angiomed U.S., Inc. | 1986-01-24 |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | Angiomed U.S., Inc. | 1986-01-24 |
| K820867 | PERCUTANEOUS NEPHROSTOMY SET | Van-Tec, Inc. | 1982-04-13 |
| K781664 | SILASTIC NEPHROSTOMY SYSTEM | Dow Corning Corp. Healthcare Industries Materials | 1979-01-22 |
| K781526 | SILASTIC U-TUBE KIT | Dow Corning Corp. Healthcare Industries Materials | 1978-09-20 |
Legacy Summary#
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FDA Review#
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