510(k) · Cleared
Recalled · Class II · 2025Resectoscope Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FJL Resectoscope
Cleared on Jul 23, 1993 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 18 times.
- Decided
- Jul 23, 1993
- Review
- 91 days
- Class
- Class II
- Product code
- FJL
- Recalls
- 18
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2025 | Class II | Z-1450-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1455-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1452-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1447-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1457-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1445-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1441-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1446-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1442-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1444-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1456-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1439-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1438-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1440-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1453-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1451-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1448-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| Nov 11, 2025 | Class II | Z-1443-2026 | Under Investigation by firm | Complaints of the ceramic tip of the resection sheath breaking have been received. |
The 5 latest of 18 recalls; the web page lists all.
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 | — |
https://510kreport.com/device/K931995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931995: Resectoscope Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931995
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026