Modified Pediatric Silicone Foley Catheters
FDA 510(k) K900031 · Porges Corp.
510(k) numberK900031
Submission
- Device name
- Modified Pediatric Silicone Foley Catheters
- Applicant
- Porges Corp.
Gary, IN, US - Received
- January 4, 1990
- Decision date
- March 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050)KNY · Traditional | Class Medical , Ltd. | 08/05/2026SE |
| K182144 | Bi-Flex EvoKNY · Special | Promepla Sam | 09/07/2018SE |
| K162356 | Vesair Cystoscopic SheathKNY · Special | Solace Therapeutics | 03/02/2017SE |
| K140441 | Bi-Flex Ureteral Access SheathKNY · Traditional | Promepla Sam | 06/17/2014SE |
| K140562 | Wijay Ez-Void External Catheter ValveKNY · Traditional | Leomed, LLC | 06/16/2014SE |
| K141252 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 06/09/2014SE |
| K131803 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 08/20/2013SE |
| K123170 | Vari-Pass Variable Length Access SheathKNY · Special | Olympus Surgical Technologies America | 02/04/2013SE |
| K120160 | Rocamed Rocaus PlatinumKNY · Traditional | Promepla Sam | 05/14/2012SE |
| K112209 | Prefilled Catheter Inflation SyringeKNY · Special | Avail Medical Products, Inc. | 09/08/2011SE |
More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900269 | Porges Dormia 3 FR Flat Wire Basket Stone DislodgeFFL · Traditional | 07/03/1990SE |
| 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 |
| K896426 | Porges SphincterotomesKNS · Traditional | 01/22/1990SE |
Questions and answers
When was Modified Pediatric Silicone Foley Catheters cleared by the FDA?
Modified Pediatric Silicone Foley Catheters (K900031) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 61 days after the submission was received.
What is the product code of K900031?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.