510(k) · Cleared
Recalled · Class II · 2023Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands
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 Jul 1, 2010 as substantially equivalent to K903323 (Olympus Corp., 1990) and 4 other predicates after a 150-day review. Its family tree reaches back 4 generations to 1991. 15 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2010
- Review
- 150 days
- Class
- Class II
- Product code
- FAS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K911904 (1991). 17 ancestors in all, the oldest K903323 (1990). 15 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 3 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 2 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 1 generation backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- This deviceK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010
- Descendant · cites it directly · 5 of its ownK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
- Descendant · cites it directly · 5 of its ownK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK120567 Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK163090 Plasma Edge SystemChirurgie Innovation · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K152092Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · cites it directly5descendants
- K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH · 2011 · cites it directly5descendants
- K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · 2 generations on3descendants
- K120567Gyrus Amci PK Button ElectrodeGyrus Acmi, Inc. · 2012 · 2 generations on3descendants
- K163090Plasma Edge SystemChirurgie Innovation · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −3 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −2 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −1 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| 0 (this device) | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | — |
| +1 | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | 1 |
| +1 | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode… | Olympus Winter & Ibe GmbH | 2011 | 1 |
| +2 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
| +2 | K120567 | Gyrus Amci PK Button Electrode | Gyrus Acmi, Inc. | 2012 | — |
| +3 | K163090 | Plasma Edge System | Chirurgie Innovation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K903323 | Resectoscope Loops Our reading of the summary gave K903233, FDA’s number for Synermed Calcium Reagent Kit (Synermed, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Resectoscope Loops”. | 1990 |
| * | K994166 | Gyrus Endourology System: Axipolar Resectoscope ElectrodeSummary page 2…Manufacturer K903233 -Resectoscope Loops Olypu K994166 -Gyrus Axipolar Resectoscope ElectrodeGyuA i K030194 Electrosurgical Unit and it… | 1999 |
| * | K030194 | Xues-41 Endoscopic Electrosurgical UnitSummary page 2…pe Loops Olypu K994166 -Gyrus Axipolar Resectoscope ElectrodeGyuA i K030194 Electrosurgical Unit and its associated accessories, HIF Oympus _ _ ~~Resection Electrode… | 2003 |
| * | K973820 | Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeSummary page 2…vice Name [Manufacturer K903233 Resectoscope Loops Olympus K973820 CIRCON AGMI USA Elite System VaporTrode Vaporization Gyrus AGMI Electrode and VaporTome Resectio… | 1998 |
| * | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories) Our reading of the summary gave K030185, FDA’s number for Endos AC/Acp (Villa Sistemi Medicali S.P.A.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Gyrus PlasmaKinetic Superpulse System”. | 2003 |
What descends from it? (15)
See all 154 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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K152092 (Olympus Winter & Ibe GmbH, 2015) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K903323.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy, transurethral…
Read the full statement (229 words)
The HF-Resection Electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and where hemostatis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis), transurethral prostatectomy, transurethral resection of the prostate (TURP) for benign prostatic hypertplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment.
These devices are not intended to be used to treating cancer of the prostate.
The HF-Resection Electrode for Plasma Vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving the vaporization, ablation, coagulation, culling, removal of soft tissue and coagulation where hemostatis is required. The specific soft tissue indications include use in the prostate, bladder and bladder neck. The specific treatment indications include benign prostate hyperplasia BPH, bladder cancer, tumors, lesions and neoplasms. The specific urological indications include transurethral electrovaporization (TUVP, TVP, TUIEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment.
These devices are not intended to be used in treating cancer of the prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100275
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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