# K033113: Universal Operating Hysteriscope Set by Solima-Zupi, Consisting of Optic, Inner and Outer Sheaths, Forceps, Model 8753

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Dec 23, 2003 after 84 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
Longest line of descent: 1 generation back to K880314 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880314: Hysteroscope Autonom 4992, Richard Wolf Medical Instruments Corp. (1988) Summary page 1.
- K000673: Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, Richard Wolf Medical Instruments Corp. (2000) Summary page 1.
- (no number) Hysteroscopes and Accessories 4998, 8998: named in the summary without a submission number

## Indications for use
The Universal Operating Hysteroscope Set is used for dilating the cervical channel, the cavum uteris (using fluid or CO 2 gas), and for visualization of the tubal ostia. The scope is applied via the natural passage.

Source page: https://510kreport.com/device/K033113
Methodology: https://510kreport.com/methodology