510(k) · Cleared
ClearedACE Electrosurgical Resection and Vaporization Electrodes Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Devices Pvt., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 11, 2016 as substantially equivalent to K120418 (Olympus Winter & Ibe GmbH, 2012) after a 265-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jul 11, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K911904 (1991). 19 ancestors in all, the oldest K903323 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 5 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 4 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 3 generations backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- 2 generations backK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- 1 generation backK120418 Electrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH · 2012 · Recalled
- This deviceK153055 ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −5 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −4 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −3 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| −2 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| −1 | K120418 | Electrosugrical Resection and Vaporization Electrode Series | Olympus Winter & Ibe GmbH | 2012 | 2 |
| 0 (this device) | K153055 | ACE Electrosurgical Resection and Vaporization Electrodes Series | Ace Medical Devices Pvt., Ltd. | 2016 | — |
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 |
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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K120418 | Electrosugrical Resection and Vaporization Electrode SeriesSummary page 5…unit, and accessories Device Class: Class II Classification Panel: Gastroenterology arid Urology 5. Legally Marketed Predicate Device(s) K120418, Electrosurgical Resection and Vaporization Electrodes Series, Olympus Winter & lbe GmbH 6. Device Description The ACE Elect… | 2012 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K120418.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis 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…
Read the full statement (247 words)
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed
and intended for use in endoscopic urological surgical procedures involving the resection, ablation or removal of soft
tissue and coagulation where hemostasis 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 (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia,
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 (0.9% Sodium Chloride). These
devices are not intended to be used to treat cancer of the prostate.
The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and
intended for use in urological surgical procedures involving the vaporization, ablation, cutting, removal of soft tissue and
coagulation where hemostasis 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 electro vaporization (TUVP, TVP, TUEVP),
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 (0.9% Sodium Chloride). 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/K153055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153055: ACE Electrosurgical Resection and Vaporization Electrodes Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153055
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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