Spec 5* Suprapubic Catheter
FDA 510(k) K881097 · Porges Corp.
510(k) numberK881097
Submission
- Device name
- Spec 5* Suprapubic Catheter
- Applicant
- Porges Corp.
Stamford, CT, US - Received
- March 15, 1988
- Decision date
- June 3, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOB – Catheter, Suprapubic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | Applied Medical Technology, Inc. | 11/01/2024SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | Cook Incorporated | 01/18/2019SESK |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | Cook Incorporated | 12/26/2018SE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional | Cook Incorporated | 10/30/2018SESK |
| K132890 | Suprapubic Catheter and Introducer SetKOB · Traditional | Mediplus , Ltd. | 01/17/2014SE |
| K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional | Swan Valley Medical, Incorporated | 10/26/2012SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | Fortune Medical Instrument Corp. | 03/04/2002SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | Circon Video | 09/19/2001SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | The Kendal Co. | 04/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | Rusch, Inc. | 02/07/1997SE |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900269 | Porges Dormia 3 FR Flat Wire Basket Stone DislodgeFFL · Traditional | 07/03/1990SE |
| K900031 | Modified Pediatric Silicone Foley CathetersKNY · Traditional | 03/06/1990SE |
| K896505 | Porges Universal HandlesGCP · Traditional | 01/30/1990SE |
| K896503 | Porges Ercp CathetersFGE · Traditional | 01/30/1990SE |
| K896507 | Porges Diathermy SnareKNS · Traditional | 01/29/1990SE |
| K896425 | Porges Cytology BrushesFDX · Traditional | 01/29/1990SE |
| K896506 | Porges Endoscopic Dormia Extractors, DormiatriptorFGE · Traditional | 01/26/1990SE |
| K896504 | Porges 2-WAY Balloon Extraction CatheterFGE · Traditional | 01/26/1990SE |
| K896424 | Porges Sclerotherapy NeedlesFBK · Traditional | 01/26/1990SE |
| K896502 | Porges Biopsy & Foreign Body ForcepsOCZ · Traditional | 01/22/1990SE |
Questions and answers
When was Spec 5* Suprapubic Catheter cleared by the FDA?
Spec 5* Suprapubic Catheter (K881097) received a 510(k) decision of Substantially Equivalent on June 3, 1988, 80 days after the submission was received.
What is the product code of K881097?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.