510(k) · Cleared
Recalled · Class II · 2025Resection Electrodes with HF cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Aug 3, 2021 as substantially equivalent to K171965 (Olympus Winter & Ibe GmbH, 2017) after a 152-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 3, 2021
- Review
- 152 days
- Class
- Class II
- Product code
- FAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K911904 (1991). 24 ancestors in all, the oldest K897003 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 6 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 5 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 4 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 3 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 2 generations backK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
- 1 generation backK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
- This deviceK210651 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2021
- Descendant · cites it directly · 0 of its ownK221893 KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −6 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −5 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −4 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −3 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −2 | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | 1 |
| −1 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
| 0 (this device) | K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 FAS? 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 FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K171965 | Resection Electrodes with HF cableSummary page 6…WA22766S, WA22740S, WA22741S, WA22742S, FAS / 876.4300 Resection Electrodes with K171965 HF cable WA22743S, WA22744S, FJL / 876.1500… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2025 | Class II | Z-1449-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
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 5.3 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K221893 (Karl Storz Endoscopy America, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171965.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the…
Read the full statement (100 words)
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.
The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system.
Specific indications:
- transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
- lysis of intrauterine septa
- endometrial ablation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210651: Resection Electrodes with HF cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210651
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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