Wang Transendoscopic Aspiration Needle
FDA 510(k) K954519 · Mill-Rose Laboratory
510(k) numberK954519
Submission
- Device name
- Wang Transendoscopic Aspiration Needle
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- September 28, 1995
- Decision date
- December 22, 1995
- 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 |
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| 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 |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
| K950559 | Diener Retrieval DevicesFCL · Traditional | 02/16/1995SE |
Questions and answers
When was Wang Transendoscopic Aspiration Needle cleared by the FDA?
Wang Transendoscopic Aspiration Needle (K954519) received a 510(k) decision of Substantially Equivalent on December 22, 1995, 85 days after the submission was received.
What is the product code of K954519?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.