510(k) · Cleared
ClearedAed Resectoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Advanced Endoscopy Devices, Inc. · FJL Resectoscope
Cleared on Dec 30, 2010 as substantially equivalent to K980302 (Richard Wolf Medical Instruments Corp., 1998) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Dec 30, 2010
- Review
- 106 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895857 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895857 Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp. · 1990
- 1 generation backK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998 · Recalled
- This deviceK102663 Aed ResectoscopeNational Advanced Endoscopy Devices, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895857 | Continuous Irrigation Resectoscope Syst/Gynecology | Richard Wolf Medical Instruments Corp. | 1990 | — |
| −1 | K980302 | Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes | Richard Wolf Medical Instruments Corp. | 1998 | 1 |
| 0 (this device) | K102663 | Aed Resectoscope | National Advanced Endoscopy Devices, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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 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 |
|---|---|---|---|
| * | K980302 | Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesSummary page 1…Electrode, Electrosurgical, Active, Urological (FAS, 21 CFR 876.4300) Predicate Devices: Resectoscope E-Line, Richard Wolf, K980302 Resectoscopes, Karl Storz, K954050 Device Description: Resectoscopes are used in transuretheral… | 1998 |
| * | K954050 | ResectoscopesSummary page 1…l (FAS, 21 CFR 876.4300) Predicate Devices: Resectoscope E-Line, Richard Wolf, K980302 Resectoscopes, Karl Storz, K954050 Device Description: Resectoscopes are used in transuretheral resection of the prostate (TURP) and… | 1995 |
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 20 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K980302.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines such as Urology and Gynecology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102663: Aed Resectoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102663
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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