# K980465: Olympus TJF-140R/JF-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Apr 21, 1998 after 75 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853585 (1986). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 1.

## Most influential descendants
- K251861: FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (2026), 0 descendants of its own
- K024033: XTJF-160AF Duodenovideoscope (2002), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0342-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Sep 25, 2023 · Class II · Z-0341-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten

## Indications for use
Olympus TJF-140R/JF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum. Olympus MAJ-311 Distal Cover is specifically designed to be attached to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. Olympus MAJ-411 Distal Cover is specifically designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.

Source page: https://510kreport.com/device/K980465
Methodology: https://510kreport.com/methodology