Porges Dormia 3 FR Flat Wire Basket Stone Dislodge
FDA 510(k) K900269 · Porges Corp.
510(k) numberK900269
Submission
- Device name
- Porges Dormia 3 FR Flat Wire Basket Stone Dislodge
- Applicant
- Porges Corp.
Gary, IN, US - Received
- January 18, 1990
- Decision date
- July 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFL – Dislodger, Stone, Basket, Ureteral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4680
- Specialty
- Gastroenterology, Urology
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| K052048 | AccordionFFL · Traditional | Percutaneous Systems, Incorporated | 09/13/2005SE |
| K012581 | Reprocessed Stone Retrieval BasketsFFL · Traditional | Sterilmed, Inc. | 02/14/2002SE |
| K972091 | Ams Foreign Body ExtratorFFL · Traditional | American Medical Systems, Inc. | 08/29/1997SE |
| K970489 | Comeg Endoscopy Grasping ForcepsFFL · Traditional | Comeg Endoscopy | 03/19/1997SE |
| K962387 | Olympus FG-45/46-1 Grasping Forceps(Urology)FFL · Traditional | Olympus America, Inc. | 07/31/1996SE |
| K961248 | Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone…FFL · Traditional | C.R. Bard, Inc. | 05/28/1996SE |
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| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K896426 | Porges SphincterotomesKNS · Traditional | 01/22/1990SE |
Questions and answers
When was Porges Dormia 3 FR Flat Wire Basket Stone Dislodge cleared by the FDA?
Porges Dormia 3 FR Flat Wire Basket Stone Dislodge (K900269) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 166 days after the submission was received.
What is the product code of K900269?
The FDA product code is FFL – Dislodger, Stone, Basket, Ureteral, Metal, a Class II (moderate risk) device regulated under 21 CFR 876.4680.