Product code KOB
- Device name
- Catheter, Suprapubic (And Accessories)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5090
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024-11-01 |
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019-01-18 |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | 2018-12-26 |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018-10-30 |
| K132890 | SUPRAPUBIC CATHETER AND INTRODUCER SET | Mediplus , Ltd. | 2014-01-17 |
| K120127 | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM | Swan Valley Medical, Incorporated | 2012-10-26 |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | Fortune Medical Instrument Corp. | 2002-03-04 |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | Circon Video | 2001-09-19 |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | The Kendal Co. | 1997-04-23 |
| K970021 | RUSCH SUPRAPUBIC TRAY | Rusch, Inc. | 1997-02-07 |
| K945480 | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER | Harry A. Schlakman | 1995-08-28 |
| K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND | Cook Urological, Inc. | 1995-08-18 |
| K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | Rusch, Inc. | 1995-07-25 |
| K921071 | DENTOLOCK | Dentmed , Ltd. | 1992-03-26 |
| K904798 | SUPRAPUBIC FLOW CONTROLLER | Olympus Corp. | 1991-11-22 |
| K904434 | SEXTON CYSTOTOMY URINE PUMP (SCUP2) | Phoenix Bioengineering, Inc. | 1991-02-01 |
| K901938 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | 1990-06-06 |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | Bivona Medical Technologies | 1990-05-04 |
| K884061 | ADD-A-CATH | Femcare , Ltd. | 1988-10-25 |
| K881097 | SPEC 5* SUPRAPUBIC CATHETER | Porges Corp. | 1988-06-03 |
| K874530 | URETHRAL DILATOR ENDOSCOPE | Advanced Surgical Intervention, Inc. | 1988-01-27 |
| K870555 | VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET | Van-Tec, Inc. | 1987-03-10 |
| K870556 | VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET | Van-Tec, Inc. | 1987-03-10 |
| K863120 | (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET | Cook Urological, Inc. | 1986-10-24 |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | Angiomed U.S., Inc. | 1986-10-24 |
| K852287 | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET | Cook Ob/Gyn | 1985-08-08 |
| K852200 | SIMPLASTIC SUPRA PUBIC CATHETER | Franklin Medical USA, Inc. | 1985-08-07 |
| K843158 | SEXTON CYSTOTOMY URINE PUMP | Holter-Hausner Intl. | 1984-10-04 |
| K813084 | CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET | Burron Medical Products, Inc. | 1981-12-31 |
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY | Vance Products, Inc. | 1981-03-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842071152765 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152901 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152895 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152888 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152871 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152864 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152857 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152840 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152833 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152826 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152819 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152802 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152796 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152789 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152772 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071152758 | MiniSPC Button | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071150976 | AMT MiniSPC Drainage Set | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071150952 | AMT MiniSPC Drainage Set | APPLIED MEDICAL TECHNOLOGY, INC. | 2026-03-18 |
| 00842071148355 | AMT MiniSPC Drainage Set | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-01-24 |
| 00842071148331 | AMT MiniSPC Drainage Set | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-01-24 |
| H671SFS181010 | SUPRA-FOLEY | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671SFS168510 | SUPRA-FOLEY | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671SFS161000 | SUPRA-FOLEY | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671SFS141040 | SUPRA-FOLEY | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| H671SFS128520 | SUPRA-FOLEY | UTAH MEDICAL PRODUCTS, INC. | 2016-09-23 |
| 00801741030390 | Bard® Pezzer-Malecot Stylet | C. R. Bard, Inc. | 2016-08-06 |
| 08569950031073 | T-SPeC | SWAN VALLEY MEDICAL, INCORPORATED | 2016-06-23 |
| 08569950031141 | T-SPeC | SWAN VALLEY MEDICAL, INCORPORATED | 2016-06-23 |
| 24026704066128 | RUSCH | TELEFLEX INCORPORATED | 2015-10-16 |
| 00801741040542 | Bard® Suprapubic Introducer Foley Catheter Set with Bardex Lubricath | C. R. Bard, Inc. | 2015-05-29 |