KOB — Catheter, Suprapubic (And Accessories) Class II
FDA product code KOB covers "Catheter, Suprapubic (And Accessories)", a Class II medical device regulated under 21 CFR 876.5090. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |