# K897003: Olympus Hysteroresectoscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Mar 16, 1990 after 88 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices 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.

## Most influential descendants
- K152092: Resection Electrodes (2015), 5 descendants of its own
- K171965: Resection Electrodes with HF cable (2017), 3 descendants of its own
- K210651: Resection Electrodes with HF cable (2021), 1 descendant of its own
- K190113: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), 1 descendant of its own
- K221893: KARL STORZ Bipolar Resectoscopes with HF Cable (2023), 0 descendants of its own

## Recalls of this device
- Apr 18, 2024 · Class II · Z-2029-2024: The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

Source page: https://510kreport.com/device/K897003
Methodology: https://510kreport.com/methodology