510(k) · Cleared
ClearedKARL STORZ Bipolar Resectoscopes with HF Cable
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 Mar 17, 2023 as substantially equivalent to K210651 (Olympus Winter & Ibe GmbH, 2021) after a 261-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Mar 17, 2023
- Review
- 261 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911904 (1991). 25 ancestors in all, the oldest K897003 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 7 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 6 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 5 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 4 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 3 generations backK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
- 2 generations backK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
- 1 generation backK210651 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2021 · Recalled
- This deviceK221893 KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −7 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −6 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −5 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −4 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −3 | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | 1 |
| −2 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
| −1 | K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021 | 1 |
| 0 (this device) | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2003 | 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 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 K230205 Veloxion Systemscore 5.8 · 4 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K210651 | Resection Electrodes with HF cableSummary page 6…: Product Code: FJL (FAS, HIH, FDC) Guidance Not Applicable Document: Predicate Resection Electrodes with HF cable (K210651) Devices: Reference KARL STORZ 27040 & 27050 Continuous Flow Resectoscopes (K882270) Devices:… | 2021 |
| † | K882270 | Models 27040 & 27050 Conti. Flow Resectoscopes | 1989 |
| † | K061541 | Ksea Bipolar Electrotome | 2006 |
| † | K122983 | Ksea Bipolar Electrode | 2013 |
| † | K171717 | Autocon Iii 400 | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 7 of the 25 ancestors have a recall of any class.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures. The following models are intended for the aforementioned use: 27040AK, 27040AO, 27040BK, 27040BO, 27040BP, 27040SD, 27040SL, 27040SM, 27040XA, 27040XB, 27050CA, 27050CB, 27050SC, 27050SD, 27050SL, 27050SM, 27050XA, 27050XB, 27051PL, 27051XA…
Read the full statement (213 words)
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The following models are intended for the aforementioned use: 27040AK, 27040AO, 27040BK, 27040BO, 27040BP, 27040SD, 27040SL, 27040SM, 27040XA, 27040XB, 27050CA, 27050CB, 27050SC, 27050SD, 27050SL, 27050SM, 27050XA, 27050XB, 27051PL, 27051XA, 27054CB, 27054SC, 27054SL, 27054XB, 27241AO, 27241BK, 27241BO, 27040BB, 27040OA, 27040OB, 27040OC, 27040OD, 27048BK, 27048CK, 27048CO, 27050AE, 27050AK, 27050BE, 27050BK, 27051A, 27051B, 27054CO, PV27051B, 27040DB, 27040EO, 27040EB, 27040BL1-S, 27040BLO1-S, 27040GD1-S, 27040GP1-S, 27040GP130-S, 27040GP140-S, 27040GPB1-S, 27040GPO1-S, 27040JB1-S, 27040JB130-S, 27040JBE130-S, 27040NB-S, 27040NBO-S, 27040VE-S.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures.
The following models are intended for the aforementioned use: 26040SL, 26040XA, 26050CA, 26050SC, 26050SL, 26050XA, 26053CB, 26053SC, 26055CB, 26055LD, 26055SC, 26055SL, 26055XB, 26055XE, 26053OC, 26055CO, 26040OC, 26053EB, 26040EB, 26055EB, 26040BL1-S, 26040GP1-S, 26040JB1-S, 26040NB-S, 26055BL1 - S, 26055GP1 - S, 26055NB- S.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
The following models are intended for the aforementioned use: 011050-10, 011051-10, 011052-10, 011160-10, 011163-10, UH801.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221893: KARL STORZ Bipolar Resectoscopes with HF Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221893
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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