510(k) · Cleared
ClearedSurgitek Graduated Cystoscope (Model GC-16)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgitek · FBO Cystourethroscope
Cleared on Mar 5, 1991 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 117 devices in its family, counting itself, has a Class I recall. 116 later devices descend from it.
- Decided
- Mar 5, 1991
- Review
- 133 days
- Class
- Class II
- Product code
- FBO
- Recalls
- None
- Predicates
- 0
116 later devices descend from it, 2 citing it directly. 1 of the 117 devices in this family, counting this one, has a Class I recall.
- This deviceK904797 Surgitek Graduated Cystoscope (Model GC-16)Surgitek · 1991
- Descendant · cites it directly · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · 2 generations on · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- Descendant · 3 generations on · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 4 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
Showing 5 of 116 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor6 generations on · 2024
Most influential descendants
Showing 5 of 116 · See all- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · cites it directly103descendants
- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · 2 generations on101descendants
- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · 3 generations on99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 4 generations on53descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904797 | Surgitek Graduated Cystoscope (Model GC-16) | Surgitek | 1991 | — |
| +1 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| +3 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +4 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +4 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 19 | 1 |
| 2025 | 19 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 FBO device
- #1 K244001 KARL STORZ Cysto-Urethro-Fiberscope…score 9.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (116)
See all 1162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030960 (Acmi Corporation, 2003) has gone furthest, with 103 descendants of its own.
How does its category compare?
All FBO devicesFBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBO
Too few FBO 510(k)s in any year since 2007 to give a median.
Recalls per year · FBO
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBO
26in 2025
MAUDE reports naming product code FBO, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 33 |
| 2023 | 0 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 1 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904797: Surgitek Graduated Cystoscope (Model GC-16).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904797
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026