# K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 17, 2002 after 57 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 K971188 (1997). 2 ancestors in all.
14 later devices descend from it; 4 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)
- K971188: Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual Instruments, Smith & Nephew, Inc. (1997) Summary page 1.
- K000673: Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, Richard Wolf Medical Instruments Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K122563: Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel (2012), 2 descendants of its own

## Indications for use
The Smith & Nephew Operative Hysteroscope and accessories are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K013870
Methodology: https://510kreport.com/methodology