Gip/Medi-Globe Sclerotherapy Needles
FDA 510(k) K955558 · Medi-Globe Corp.
510(k) numberK955558
Submission
- Device name
- Gip/Medi-Globe Sclerotherapy Needles
- Applicant
- Medi-Globe Corp.
Tempe, AZ, US - Received
- December 6, 1995
- Decision date
- February 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | 04/16/2026SE |
| K153264 | EasyPass GuidewireOCY · Traditional | 05/19/2016SE |
| K142258 | PolyCatch Retrieval DeviceFDI · Traditional | 09/30/2014SE |
| K133763 | Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemFCG · Traditional | 05/15/2014SE |
| K091257 | Medi-Globe Sonotip II Ebus-Tbna Needle SystemFCG · Traditional | 05/08/2009SE |
| K083802 | Sonotip II 25-GAUGE Ultrasound Needle System, Models GUS-01-18-025 and GUS-01-27-025FCG · Traditional | 03/20/2009SE |
| K070129 | Sonotip II Ultrasound Needle SystemFCG · Traditional | 01/31/2007SE |
| K061222 | Injectra Injection NeedleFBK · Traditional | 07/03/2006SE |
| K061684 | Medi-Globe Rota-Cut SphincterotomeKNS · Traditional | 06/27/2006SE |
| K051247 | Sonotip II Ultrasound Needle SystemFCG · Special | 06/16/2005SE |
Questions and answers
When was Gip/Medi-Globe Sclerotherapy Needles cleared by the FDA?
Gip/Medi-Globe Sclerotherapy Needles (K955558) received a 510(k) decision of Substantially Equivalent on February 29, 1996, 85 days after the submission was received.
What is the product code of K955558?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.