FDI — Snare, Flexible Class II
FDA product code FDI covers "Snare, Flexible", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FDI
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251692 | micro-tech (nanjing) co | Advanced Tissue Resection Device | February 21, 2026 |
| K221713 | hangzhou ags medtech co | Polypectomy Snare | March 3, 2023 |
| K220846 | incore co | CORE-SNARE | November 21, 2022 |
| K220089 | jiangsu vedkang medical science and technology co | Disposable Polyp Snare | September 22, 2022 |
| K220790 | yangzhou fartley medical instrument technology co | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | June 27, 2022 |
| K213222 | beijing zksk technology co | Disposable Polypectomy Snare | June 6, 2022 |
| K212860 | steris corporation | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- | October 7, 2021 |
| K202478 | boston scientific corporation | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare | October 8, 2020 |
| K200745 | united states endoscopy group | Lariat, Hot/Cold Snare | April 21, 2020 |
| K190512 | intelligent endoscopy | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | November 22, 2019 |
| K191048 | wilson-cook medical | AcuSnare Polypectomy Snare - Duckbill | July 18, 2019 |
| K183289 | finemedix co | ClearGrasp Snare | March 6, 2019 |
| K182909 | united states endoscopy group | Roth Net Retriever Product Line | November 21, 2018 |
| K173673 | wilson-cook medical | AcuSnare Polypectomy Snare | August 24, 2018 |
| K172729 | hangzhou ags medtech co | Polypectomy Snare | May 21, 2018 |
| K172758 | zhejiang chuangxiang medical technology co | Rotatable Snares, Non-Rotatable Snares | March 7, 2018 |
| K172734 | olympus medical systems | Single Use Electrosurgical Snare SD-400 | December 7, 2017 |
| K160637 | boston scientific corporation | Rotatable Snares | March 30, 2016 |
| K152580 | endochoice | rescuenet | November 3, 2015 |
| K150316 | micro-tech (nanjing) co | Polypectomy Snare | July 30, 2015 |