FDA Product Code
FDA Product Code FDA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260314 | Ancora-SB | Aspero Medical, Inc. | 2026-05-01 | Traditional | PDF ↗ |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025-09-26 | Traditional | PDF ↗ |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FUJIFILM Healthcare Americas Corporation | 2024-06-13 | Traditional | PDF ↗ |
| K231323 | Ancora-SB | Aspero Medical, Inc. | 2023-08-31 | Traditional | PDF ↗ |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D | Fujifilm Corporaton | 2023-01-11 | Special | PDF ↗ |
| K213195 | Balloon BS-3 | Fujifilm Corporation | 2021-10-29 | Special | PDF ↗ |
| K191330 | Arc Enterocuff | Boddingtons Plastics, Ltd. | 2020-01-31 | Traditional | PDF ↗ |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BT | Fujifilm Corporation | 2019-06-24 | Traditional | PDF ↗ |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation | 2019-02-27 | Special | PDF ↗ |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 | Traditional | PDF ↗ |
| K071254 | SMALL INTESTINAL VIDEOSCOPE SYSTEM | Olympus Medical Systems Corporation | 2008-03-25 | Traditional | PDF ↗ |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | Smart Medical Systems , Ltd. | 2006-08-15 | Traditional | PDF ↗ |
| K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K040048 | FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM | Fujinon, Inc. | 2004-06-07 | Traditional | PDF ↗ |
| K031256 | XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE | Olympus Opto-Electronics Co., Ltd. | 2003-07-23 | Traditional | PDF ↗ |
| K993704 | GASTRO-INTESTINAL SYSTEM EN-410WM | Fujinon, Inc. | 2000-02-11 | Traditional | PDF ↗ |
| K904800 | SIF-SW | Olympus Corp. | 1991-03-27 | Traditional | PDF ↗ |
| K840722 | ENTEROSCOPE | Trimedyne, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841396 | TRANSFER TROLLEY | Setma, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K810757 | I.V. ADMINISTRATION SET | American Mcgaw | 1981-04-08 | Traditional | PDF ↗ |
Product code FDA · Class II · Gastroenterology, Urology. Data: openFDA.