# K931995: Resectoscope Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Jul 23, 1993 after 91 days
- Product code: FJL (Resectoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 11, 2025 · Class II · Z-1450-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1455-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1452-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1447-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1457-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1445-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1441-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1446-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1442-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1444-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1456-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1439-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1438-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1440-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1453-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1451-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1448-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Nov 11, 2025 · Class II · Z-1443-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.

Source page: https://510kreport.com/device/K931995
Methodology: https://510kreport.com/methodology