510(k) · Cleared
ClearedComeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comeg Endoscopy · FJL Resectoscope
Cleared on Aug 12, 1997 after an 84-day review. The FDA summary names its predicate without a number. 56 later devices descend from it.
- Decided
- Aug 12, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 3 citing it directly.
- This deviceK971881 Comeg Resectoscope and Laser-Resectoscope Working…Comeg Endoscopy · 1997
- Descendant · cites it directly · 52 of its ownK990628 Gyrus Endourology SystemGyrus Medical, Ltd. · 1999
- Descendant · 2 generations on · 49 of its ownK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- Descendant · 3 generations on · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- Descendant · 4 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · 2 generations on · 16 of its ownK994166 Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd. · 1999
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K990628Gyrus Endourology SystemGyrus Medical, Ltd. · 1999 · cites it directly52descendants
- K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · 2 generations on49descendants
- K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · 3 generations on22descendants
- K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 4 generations on16descendants
- K994166Gyrus Endourology System: Axipolar Resectoscope ElectrodeGyrus Medical, Ltd. · 1999 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971881 | Comeg Resectoscope and Laser-Resectoscope Working… | Comeg Endoscopy | 1997 | — |
| +1 | K990628 | Gyrus Endourology System | Gyrus Medical, Ltd. | 1999 | — |
| +2 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| +3 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| +4 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +2 | K994166 | Gyrus Endourology System: Axipolar Resectoscope Electrode | Gyrus Medical, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Karl Storz Named without a submission number | |
| * | — | Circon ACMI Named without a submission number |
What descends from it? (56)
See all 563 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990628 (Gyrus Medical, Ltd., 1999) has gone furthest, with 52 descendants of its own.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement…
Read the full statement (223 words)
Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.
Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.
Urethrotomes are intended to be used in urological procedures to endoscopically cut and or transect tissue(strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome knife will be extended an the entire urethrotome will be extracted cutting the affected area.
Electrodes are intended to be used endoscopically im conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971881: Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971881
Report an extraction error
Are you the manufacturer?
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