KOB · Catheter, Suprapubic (And Accessories)
Gastroenterology, Urology · 21 CFR 876.5090 · Class 2
Overview
| Product Code | KOB |
|---|---|
| Device Name | Catheter, Suprapubic (And Accessories) |
| Regulation | 21 CFR 876.5090 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
Identification
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | Nov 1, 2024 | SESE |
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | Jan 18, 2019 | SESK |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | Dec 26, 2018 | SESE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | Oct 30, 2018 | SESK |
| K132890 | SUPRAPUBIC CATHETER AND INTRODUCER SET | Mediplus , Ltd. | Jan 17, 2014 | SESE |
| K120127 | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM | Swan Valley Medical, Incorporated | Oct 26, 2012 | SESE |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | Fortune Medical Instrument Corp. | Mar 4, 2002 | SESE |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | Circon Video | Sep 19, 2001 | SESE |
| K970969 | KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET | The Kendal Co. | Apr 23, 1997 | SESE |
| K970021 | RUSCH SUPRAPUBIC TRAY | Rusch, Inc. | Feb 7, 1997 | SESE |
| K945480 | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER | Harry A. Schlakman | Aug 28, 1995 | SESE |
| K953024 | LINDNER/GOLOMB SP INTRODUCING SOUND | Cook Urological, Inc. | Aug 18, 1995 | SESE |
| K952187 | RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE | Rusch, Inc. | Jul 25, 1995 | SESE |
| K921071 | DENTOLOCK | Dentmed , Ltd. | Mar 26, 1992 | SESE |
| K904798 | SUPRAPUBIC FLOW CONTROLLER | Olympus Corp. | Nov 22, 1991 | SESE |
| K904434 | SEXTON CYSTOTOMY URINE PUMP (SCUP2) | Phoenix Bioengineering, Inc. | Feb 1, 1991 | SESE |
| K901938 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | Jun 6, 1990 | SESE |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | Bivona Medical Technologies | May 4, 1990 | SESE |
| K884061 | ADD-A-CATH | Femcare , Ltd. | Oct 25, 1988 | SESE |
| K881097 | SPEC 5* SUPRAPUBIC CATHETER | Porges Corp. | Jun 3, 1988 | SESE |
Top Applicants
- Cook Incorporated — 3 clearances
- Cook Urological, Inc. — 2 clearances
- Rusch, Inc. — 2 clearances
- Van-Tec, Inc. — 2 clearances
- Vance Products, Inc. — 2 clearances
