# K000673: Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: May 26, 2000 after 88 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 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
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224 (2002), 14 descendants of its own
- K112134: Truclear Operative Hysteroscope (2011), 7 descendants of its own
- K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C (2015), 6 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own
- K091465: Myosure Rod Lens Hysteroscope (2009), 4 descendants of its own

Source page: https://510kreport.com/device/K000673
Methodology: https://510kreport.com/methodology