510(k) · Cleared
ClearedResectoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FJL Resectoscope
Cleared on Nov 22, 1995 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Nov 22, 1995
- Review
- 85 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 6 of its ownK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
- Descendant · 2 generations on · 4 of its ownK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K991563Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…Henke Sass Wolf of America, Inc. · 1999 · cites it directly6descendants
- K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009 · 2 generations on4descendants
- K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012 · 3 generations on2descendants
- K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018 · 3 generations on1descendant
- K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| +2 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| +3 | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel | Hologic, Inc. | 2012 | — |
| +3 | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018 | — |
| +1 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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.
Planning a device in FJL? 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 FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · 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? (10)
3 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?
- Of its descendants, K991563 (Henke Sass Wolf of America, Inc., 1999) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, 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 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954050: Resectoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954050
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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