# K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 2, 2015 after 30 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: 3 generations back to K971188 (1997). 4 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K112134: Truclear Operative Hysteroscope, Smith & Nephew, Inc. (2011) Summary page 4.

## Most influential descendants
- 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
- K191958: Aveta System (2019), 0 descendants of its own

## Indications for use
The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K152143
Methodology: https://510kreport.com/methodology