510(k) · Cleared
ClearedCysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FBO Cystourethroscope
Cleared on Aug 10, 2001 as substantially equivalent to K980302 (Richard Wolf Medical Instruments Corp., 1998) after an 87-day review. Its family tree reaches back 2 generations to 1990. 12 later devices descend from it.
- Decided
- Aug 10, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- FBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895857 (1990). 3 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK895857 Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp. · 1990
- 1 generation backK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998 · Recalled
- This deviceK011496 Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators…Richard Wolf Medical Instruments Corp. · 2001
- Descendant · cites it directly · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 2 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 3 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
- Descendant · 2 generations on · 7 of its ownK150831 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015
- Descendant · 3 generations on · 6 of its ownK172844 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · cites it directly10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 2 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 3 generations on7descendants
- K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2015 · 2 generations on7descendants
- K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895857 | Continuous Irrigation Resectoscope Syst/Gynecology | Richard Wolf Medical Instruments Corp. | 1990 | — |
| −1 | K980302 | Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes | Richard Wolf Medical Instruments Corp. | 1998 | 1 |
| 0 (this device) | K011496 | Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts… | Richard Wolf Medical Instruments Corp. | 2001 | — |
| +1 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +2 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +3 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
| +2 | K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015 | — |
| +3 | K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 FBO? 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? (2)
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 |
|---|---|---|---|
| * | K980302 | Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesSummary page 4…ones Common name: C sto-Urethroscopes and accessones 510(k) Trade or proprietary or model name Manufacturer Number 1 pre- 1 Cysto-Urethroscopes 1 Richard Wolf amend. 2 K980302 |2 Resectoscopes, Instruments and 2 Richard Wolf Accessories E-Line 12-1 1.0 20 4.0 5.0 6.0 7.0 MECICAL IN… | 1998 |
| * | — | Pre-amendment Cysto-Urethroscopes Named without a submission number |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 1 company; a new generation was cleared every 8.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K132389 (Daniel & Daniel Consulting, 2014) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K980302.
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 | — |
What is it indicated for?
The Cysto-Urethroscopes “E-Line” and Accessories are used to visualize and manipulate bladder, urethra and ureter via natural passages. The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage. The obturator/viewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed. The inserts are used to guide and angle flexible…
Read the full statement (126 words)
The Cysto-Urethroscopes “E-Line” and Accessories are used to visualize and manipulate bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/viewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011496
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026