FDA Product Code
FDA Product Code FDT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 | Fujifilm Corporation | 2026-03-09 | Traditional | PDF ↗ |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315) | Olympus Medical Systems Corp. | 2026-02-22 | Traditional | PDF ↗ |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-09-19 | Traditional | PDF ↗ |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | 2025-06-05 | Traditional | PDF ↗ |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | Pentax of America, Inc. | 2024-08-01 | Traditional | PDF ↗ |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2 | Ambu A/S | 2024-04-16 | Traditional | PDF ↗ |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2022-05-11 | Traditional | PDF ↗ |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | 2021-04-09 | Special | PDF ↗ |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | 2021-04-01 | Traditional | PDF ↗ |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-12-08 | Traditional | PDF ↗ |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | 2020-10-30 | Special | PDF ↗ |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | 2020-07-17 | Traditional | PDF ↗ |
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | 2020-01-17 | Traditional | PDF ↗ |
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | Boston Scientific Corporation | 2019-12-13 | Traditional | PDF ↗ |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | Pentax of America, Inc. | 2019-11-15 | Traditional | PDF ↗ |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | Pentax Medical | 2019-10-21 | Traditional | PDF ↗ |
| K191747 | FUJIFILM Duodenoscope Model ED-580XT | Fujifilm Corporation | 2019-09-27 | Traditional | PDF ↗ |
| K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2019-03-28 | Traditional | PDF ↗ |
| K182051 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | 2018-10-02 | Special | PDF ↗ |
| K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax of America, Inc. | 2018-07-09 | Special | PDF ↗ |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | Pentax Medical | 2018-02-07 | Traditional | PDF ↗ |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Medical | 2017-09-20 | Traditional | PDF ↗ |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 | Traditional | PDF ↗ |
| K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V | Olympus Medical Systems Corp. | 2016-01-15 | Traditional | PDF ↗ |
| K110833 | CRE BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2011-04-20 | Special | PDF ↗ |
| K092710 | PENTAX ED-3490TK, VIDEO DUODENOSCOPE | Pentax Medical Company | 2009-12-02 | Traditional | PDF ↗ |
| K080403 | XTJF TYPE Q160VF1 | Olympus Medical Systems Corporation | 2008-05-20 | Traditional | PDF ↗ |
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 | Fujinon, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE | Olympus Optical Co., Ltd. | 2002-12-20 | Traditional | PDF ↗ |
| K980465 | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS | Olympus America, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K962212 | KARL STORZ FRIMBERGER VARIOGUIDE | KARL STORZ Endoscopy-America, Inc. | 1996-12-13 | Traditional | PDF ↗ |
| K963056 | ED-3410, VIDEO DUODENOSCOPE | Pentax Precision Instrument Corp. | 1996-10-10 | Traditional | PDF ↗ |
| K961568 | ED-344OT | Pentax Precision Instrument Corp. | 1996-07-09 | Traditional | PDF ↗ |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Olympus Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K832006 | PENTAX FD-34A DUODENOFIBERSCOPE | Pentax Precision Instrument Corp. | 1983-08-01 | Traditional | PDF ↗ |
Product code FDT · Class II · Gastroenterology, Urology. Data: openFDA.