510(k) · Cleared
ClearedFlexilux II Cystoscope and Hysteroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schoelly Imaging, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Mar 2, 2007 as substantially equivalent to K992437 (Fiber Imaging Technologies, Inc., 1999) and 2 other predicates after a 333-day review. Its family tree reaches back 3 generations to 1977. 19 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 333 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K770378 (1977). 11 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
- 2 generations backK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- 1 generation backK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- This deviceK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- Descendant · cites it directly · 18 of its ownK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 3 of its ownK190639 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · cites it directly18descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 2 generations on7descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 2 generations on5descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 3 generations on4descendants
- K190639Endosee SystemCooperSurgical, Inc. · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770378 | Laparoscope, Fiber Light, Palmer-Jacobs | Richard Wolf Medical Instruments Corp. | 1977 | — |
| −2 | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| −1 | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| 0 (this device) | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| +1 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| +2 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +2 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +3 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +4 | K190639 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992437 | Schoelly Rigid EndoscopesSummary page 1…ope and Accessories Product code: HIH, Regulation number 884.1720 Predicate Devices Sch6lly Laparoscope for General and Plastic Surgery (K992437) ASAP Endoscope for Obstetrics and Gynecology (K031 974) ASAP Endoscope for Gas… | 1999 |
| * | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00…Summary page 1…r 884.1720 Predicate Devices Sch6lly Laparoscope for General and Plastic Surgery (K992437) ASAP Endoscope for Obstetrics and Gynecology (K031 974) ASAP Endoscope for Gastroenterology and Urology (K(031141) Indications for Use: The Flexilux 11Cystosco… | 2003 |
| * | K031141 | Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap OesophagoscopeSummary page 1…ry (K992437) ASAP Endoscope for Obstetrics and Gynecology (K031 974) ASAP Endoscope for Gastroenterology and Urology (K(031141) Indications for Use: The Flexilux 11Cystoscope is - like the predicate device - used to permit direct viewing of the male urethr… | 2003 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | 2015 | 18 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K150158 (Schoelly Fiberoptic GmbH, 2015) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K992437.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060899: Flexilux II Cystoscope and Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060899
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026