# K002231: LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Jan 30, 2001 after 190 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931154 (1993). 6 ancestors in all.
83 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 4.

## Most influential descendants
- K011869: Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment (2001), 82 descendants of its own
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303 (2004), 67 descendants of its own
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own
- K073036: Fore-Sight, MC-2000 Series (2008), 59 descendants of its own
- K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040 (2006), 59 descendants of its own

## Indications for use
Olympus LF —DP Gastrointestinal and Sigmoid Fiberscope, accessories and ancillary equipment are inetend for observation of the upper and lower digestive tract including esophagus, stomach, and sigmoid colon.

Source page: https://510kreport.com/device/K002231
Methodology: https://510kreport.com/methodology