510(k) · Cleared
Recalled · Class II · 2023Resection Electrodes
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 Oct 26, 2015 as substantially equivalent to K897003 (Olympus Corp., 1990) and 5 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 26, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- FAS
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 5 generations to K911904 (1991). 22 ancestors in all, the oldest K897003 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 4 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 3 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 2 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 1 generation backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- This deviceK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015
- Descendant · cites it directly · 3 of its ownK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK210651 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK221893 KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK210394 Electrosurgical accessoryDornier Medtech America, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK161600 Resection ElectrodesOlympus Winter & Ibe GmbH · 2016
Most influential descendants
Showing 5 of 5 · See all- K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · cites it directly3descendants
- K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2021 · 2 generations on1descendant
- K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023 · 3 generations on0descendants
- K210394Electrosurgical accessoryDornier Medtech America, Inc. · 2021 · 2 generations on0descendants
- K161600Resection ElectrodesOlympus Winter & Ibe GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −4 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −3 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −2 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −1 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| 0 (this device) | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | — |
| +1 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
| +2 | K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021 | 1 |
| +3 | K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023 | — |
| +2 | K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | 2021 | — |
| +1 | K161600 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K897003 | Olympus HysteroresectoscopeSummary page 8…Product code / No. Reg No. Olympus A2184, A2189, A2193, K897003 HIH / 884.1690 Hysteroresectoscope A4516… | 1990 |
| * | K903323 | Resectoscope LoopsSummary page 8…A2183S, A2184S, A2185S, A2189S, A2193S, A2195S, K903323 Resectoscope Loops A2203S, A2204S, KNS / 876.4300 A2205S,… | 1990 |
| * | K931764 | HF Resection Electrode, Loop W/Runner Hyster/AccesSummary page 8…A2205S, A4513S, A4514S, A4515S, A4513US, A4514US HF Resection Electrode, K931764 Loop w/runner A2186, A2228 HIH / 884.1690 Hyster/Acces K954488 Roller Ele… | 1994 |
| * | K954488 | Roller ElectrodeSummary page 8…A4513US, A4514US HF Resection Electrode, K931764 Loop w/runner A2186, A2228 HIH / 884.1690 Hyster/Acces K954488 Roller Electrode A2158S HIH / 884.1690 HF-Resection Electrode,… | 1997 |
| * | K931763 | HF-Resection Electrode, Loop W/Runner Endos/AccessSummary page 8…2158S HIH / 884.1690 HF-Resection Electrode, FAS / 876.4300 K931763 Loop w/runner A2186 Hyster/Acces… | 1994 |
| * | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Summary page 8…Resection Button Electrode WA22355C, WA22503D, for Plasma Vaporization, FAS / 876.4300 K100275 WA22507D, WA22521C, HF-Resection Electrode GEI / 878.440… | 2010 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2023 | Class II | Z-2413-2023 | Process design | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K171965 (Olympus Winter & Ibe GmbH, 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K897003.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current. General intended use Urology Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current. Gynecology Electrodes are part of a resectoscope…
Read the full statement (262 words)
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
Gynecology
Electrodes 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 non-conducting irrigation fluid.
The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS
Specific intended use
Gynecology
- Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometriXP
- Lysis of intrauterine septa
- Endometrial ablation
The following products are not intended to be used in gynecology: WA22202S, WA22203S, WA22222S, WABD10MS, WALP06MS, WALP08MS
General intended use
Urology
Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications. Cutting, ablation, resection, vaporization and coagulation with HF current.
The following product is not intended to be used in urology: WA47056S
Gynecology
Electrodes 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 non-conducting irrigation fluid.
Specific intended use
Gynecology
- Transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometriXP
- Lysis of intrauterine septa
- Endometrial ablation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152092: Resection Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152092
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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