Varices Injection Needle
FDA 510(k) K012977 · Endo-Therapeutics, Inc.
510(k) numberK012977
Submission
- Device name
- Varices Injection Needle
- Applicant
- Endo-Therapeutics, Inc.
Safety Harbor, FL, US - Received
- September 5, 2001
- Decision date
- November 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K090796 | Multi-Bite Hot Biopsy ForcepsKGE · Traditional | 11/25/2009SE |
| K031026 | Eti Bipolar Hemostatic ProbeKNS · Traditional | 06/27/2003SE |
| K023603 | Endo-Glide GuidewireOCY · Traditional | 02/19/2003SE |
| K012725 | Tissue Grasping Forceps, Scissors, Clamps and Dissectors for Laparoscopic SurgeriesGEI · Traditional | 11/08/2001SE |
| K926549 | Endocath Electrophysiology CatheterDRF · Traditional | 12/06/1993SE |
| K925392 | Biopsy ForcepsFCL · Traditional | 11/05/1993SE |
Questions and answers
When was Varices Injection Needle cleared by the FDA?
Varices Injection Needle (K012977) received a 510(k) decision of Substantially Equivalent on November 2, 2001, 58 days after the submission was received.
What is the product code of K012977?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.