# K060899: Flexilux II Cystoscope and Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Imaging, Inc.
- Decided: Mar 2, 2007 after 333 days
- Product code: FAJ (Cystoscope 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 K770378 (1977). 11 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992437: Schoelly Rigid Endoscopes, Fiber Imaging Technologies, Inc. (1999) Summary page 1.
- K031974: Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0, Asap Endoscopic Products GmbH (2003) Summary page 1.
- K031141: Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope, Asap Endoscopic Products GmbH (2003) Summary page 1.

## Most influential descendants
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own
- K190639: Endosee System (2019), 3 descendants of its own

## Indications for use
The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures. The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K060899
Methodology: https://510kreport.com/methodology