# K112134: Truclear Operative Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 22, 2011 after 118 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: 2 generations back to K971188 (1997). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C (2015), 6 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own
- K213171: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (2022), 1 descendant of its own
- K223813: Aveta System 2.0 (2023), 0 descendants of its own
- K192100: Aveta Disposable Hysteroscope (2019), 0 descendants of its own

## Indications for use
The Smith & Nephew IRUCLEAR Operative Hysteroscope is 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/K112134
Methodology: https://510kreport.com/methodology