# K922826: Flexible Fiber Optic Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Optimed Technologies, Inc.
- Decided: Feb 19, 1993 after 253 days
- Product code: FGA (Kit, Nephroscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K072521: Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath (2007), 0 descendants of its own

## Recalls of this device
- Oct 5, 2010 · Not classified · Z-1935-2011: The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can 

Source page: https://510kreport.com/device/K922826
Methodology: https://510kreport.com/methodology