FDS
- 产品代码
- FDS
- 器械名称
- Gastroscope And Accessories, Flexible/Rigid
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 78 件
FDA 分类定义
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260824 | 2026-08-27 | Olympus Medical Systems Corporation | Gastrointestinal Videoscope Olympus GIF-2T1500 摘要 |
| K260856 | 2026-08-27 | Olympus Medical Systems Corporation | Disposable Distal Attachment D-201-13404 摘要 |
| K253702 | 2026-08-07 | Intuitive Surgical, Inc. | Intuitive Endoluminal Gastrointestinal System (IG100 摘要 |
| K260573 | 2026-04-21 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System 摘要 |
| K250550 | 2026-02-17 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Displ 摘要 |
| K253568 | 2026-02-06 | Fujifilm Corporation | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood 摘要 |
| K251256 | 2025-12-16 | Pentax of America, Inc. | PENTAX Medical Video Upper GI Scopes (EG Family) (EG 摘要 |
| K251041 | 2025-10-31 | Actuated Medical, Inc. | GripTract-GI Endoscopic Tissue Manipulator Upper GI 摘要 |
| K251708 | 2025-10-10 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System 摘要 |
| K243388 | 2025-06-27 | Micro-Tech (Nanjing) Co., Ltd. | Disposable Distal Cap 摘要 |
| K250900 | 2025-06-16 | EvoEndo, Inc. | EvoEndo Single-Use Endoscopy System 摘要 |
| K243512 | 2025-06-10 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope 摘要 |
| K242635 | 2025-05-30 | Alton (Shanghai) Medical Instruments C | Endoscopic Distal Attachment (AF-D series) 摘要 |
| K250296 | 2025-05-01 | Olympus Medical Systems Corp. | Disposable Distal Attachment D-201 Series 摘要 |
| K241213 | 2024-12-06 | Pentax of America, Inc. | PENTAX Medical Video Upper GI Scope (EG27-i20c); PEN 摘要 |
| K242779 | 2024-10-11 | Fujifilm Corporation | Hood (DH-083ST) 摘要 |
| K240142 | 2024-09-04 | Fujifilm Corporation | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope 摘要 |
| K232997 | 2024-06-19 | Olympus Medical Systems Corporation | EVIS Exera III Gastrointestinal Videoscope GIF-1TH19 摘要 |
| K232919 | 2024-04-05 | Ambu A/S | Ambu® aScope Gastro Large; Ambu® aBox 2 摘要 |
| K232028 | 2023-11-17 | Iq Endoscopes Limited | Q Vision Sterile Single Use Adult Flexible Gastrosco 摘要 |
FDA 官方分类页： FDS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。