KOB — Catheter, Suprapubic (And Accessories) Class II
FDA Device Classification
Classification Details
- Product Code
- KOB
- Device Class
- Class II
- Regulation Number
- 876.5090
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240514 | applied medical technology | AMT Low-Profile Suprapubic Catheter & Drainage Set | November 1, 2024 |
| K181097 | cook incorporated | Cook Cystostomy Catheter Set | January 18, 2019 |
| K182709 | cook incorporated | One-Step Suprapubic Introducer | December 26, 2018 |
| K182066 | cook incorporated | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | October 30, 2018 |
| K132890 | mediplus | SUPRAPUBIC CATHETER AND INTRODUCER SET | January 17, 2014 |
| K120127 | swan valley medical, incorporated | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SY | October 26, 2012 |
| K014002 | fortune medical instrument | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | March 4, 2002 |
| K012153 | circon video | LOWSLEY SUPRAPUBIC TRACTOR | September 19, 2001 |
| K970969 | kendal | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | April 23, 1997 |
| K970021 | rusch | RUSCH SUPRAPUBIC TRAY | February 7, 1997 |
| K945480 | harry a. schlakman | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER | August 28, 1995 |
| K953024 | cook urological | LINDNER/GOLOMB SP INTRODUCING SOUND | August 18, 1995 |
| K952187 | rusch | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | July 25, 1995 |
| K921071 | dentmed | DENTOLOCK | March 26, 1992 |
| K904798 | olympus | SUPRAPUBIC FLOW CONTROLLER | November 22, 1991 |
| K904434 | phoenix bioengineering | SEXTON CYSTOTOMY URINE PUMP (SCUP2) | February 1, 1991 |
| K901938 | teledyne getz | SUPER STRENGTH DENTURE ADHESIVE CREAM | June 6, 1990 |
| K901603 | bivona medical technologies | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | May 4, 1990 |
| K884061 | femcare | ADD-A-CATH | October 25, 1988 |
| K881097 | porges | SPEC 5* SUPRAPUBIC CATHETER | June 3, 1988 |