Porges Sclerotherapy Needles
FDA 510(k) K896424 · Porges Corp.
510(k) numberK896424
Submission
- Device name
- Porges Sclerotherapy Needles
- Applicant
- Porges Corp.
Gary, IN, US - Received
- November 8, 1989
- Decision date
- January 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
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|---|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 05/29/2026SE |
| K253598 | InjecSURE Injection SystemFBK · Traditional | Carbon Medical Technologies, Inc. | 03/31/2026SE |
| K252021 | Disposable Endoscopic Injection NeedlesFBK · Traditional | Changzhou New Med Micro-Medtech Co., Ltd. | 12/02/2025SE |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…FBK · Traditional | Olympus Medical Systems Corporation | 10/16/2025SE |
| K241595 | EzVu Visual Vasopressor injector (EV-19)FBK · Traditional | Veol Medical Technologies Pvt , Ltd. | 02/27/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 10/04/2024SE |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | Laborie Medical Technologies, Corp. | 08/27/2024SE |
| K232200 | Disposable Injection NeedlesFBK · Traditional | Ningbo Xinwell Medical Technology Co., Ltd. | 04/12/2024SE |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…FBK · Traditional | Steris | 03/08/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/09/2023SE |
More from Zhejiang Soudon Medical Technology Co., Ltd.
| 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 |
| K896502 | Porges Biopsy & Foreign Body ForcepsOCZ · Traditional | 01/22/1990SE |
| K896426 | Porges SphincterotomesKNS · Traditional | 01/22/1990SE |
Questions and answers
When was Porges Sclerotherapy Needles cleared by the FDA?
Porges Sclerotherapy Needles (K896424) received a 510(k) decision of Substantially Equivalent on January 26, 1990, 79 days after the submission was received.
What is the product code of K896424?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.