510(k) · Cleared
Cleared[Specialized Tissue Aspirating Resectoscope (Star)]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynecare Innovation Center · FJL Resectoscope
Cleared on Sep 16, 1996 after an 81-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 16, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | FemRx STAR System Named without a submission number |
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.
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?
The FemRx STAR System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection, morcellation and aspiration of tissue in the urethra, prostate and bladder.
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/K962506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962506: [Specialized Tissue Aspirating Resectoscope (Star)].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962506
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026