FDA Product Code
FDA Product Code KOB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5090
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024-11-01 | Traditional | PDF ↗ |
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019-01-18 | Traditional | PDF ↗ |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | 2018-12-26 | Traditional | PDF ↗ |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018-10-30 | Traditional | PDF ↗ |
| K132890 | SUPRAPUBIC CATHETER AND INTRODUCER SET | Mediplus , Ltd. | 2014-01-17 | Traditional | PDF ↗ |
| K120127 | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM | Swan Valley Medical, Incorporated | 2012-10-26 | Traditional | PDF ↗ |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | Fortune Medical Instrument Corp. | 2002-03-04 | Traditional | PDF ↗ |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | Circon Video | 2001-09-19 | Traditional | PDF ↗ |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | The Kendal Co. | 1997-04-23 | Traditional | PDF ↗ |
| K970021 | RUSCH SUPRAPUBIC TRAY | Rusch, Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K945480 | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER | Harry A. Schlakman | 1995-08-28 | Traditional | PDF ↗ |
| K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND | Cook Urological, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | Rusch, Inc. | 1995-07-25 | Traditional | PDF ↗ |
| K921071 | DENTOLOCK | Dentmed , Ltd. | 1992-03-26 | Traditional | PDF ↗ |
| K904798 | SUPRAPUBIC FLOW CONTROLLER | Olympus Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K904434 | SEXTON CYSTOTOMY URINE PUMP (SCUP2) | Phoenix Bioengineering, Inc. | 1991-02-01 | Traditional | PDF ↗ |
| K901938 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | 1990-06-06 | Traditional | PDF ↗ |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | Bivona Medical Technologies | 1990-05-04 | Traditional | PDF ↗ |
| K884061 | ADD-A-CATH | Femcare , Ltd. | 1988-10-25 | Traditional | PDF ↗ |
| K881097 | SPEC 5* SUPRAPUBIC CATHETER | Porges Corp. | 1988-06-03 | Traditional | PDF ↗ |
| K874530 | URETHRAL DILATOR ENDOSCOPE | Advanced Surgical Intervention, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K870555 | VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K870556 | VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K863120 | (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET | Cook Urological, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | Angiomed U.S., Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K852287 | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET | Cook Ob/Gyn | 1985-08-08 | Traditional | PDF ↗ |
| K852200 | SIMPLASTIC SUPRA PUBIC CATHETER | Franklin Medical USA, Inc. | 1985-08-07 | Traditional | PDF ↗ |
| K843158 | SEXTON CYSTOTOMY URINE PUMP | Holter-Hausner Intl. | 1984-10-04 | Traditional | PDF ↗ |
| K813084 | CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET | Burron Medical Products, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY | Vance Products, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K800607 | SUPRAPUBIC TROCAR | G.D. Searle and Co. | 1980-04-08 | Traditional | PDF ↗ |
| K780765 | PERCUTANEOUS SURAPUBIC CATHETER | Vance Products, Inc. | 1978-07-17 | Traditional | PDF ↗ |
Product code KOB · Class II · Gastroenterology, Urology. Data: openFDA.