# K180496: TruClear Elite Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 29, 2018 after 184 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: 4 generations back to K971188 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 4.
- K152143: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C, Smith & Nephew, Inc. (2015) Summary page 4.

## Indications for use
The TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Source page: https://510kreport.com/device/K180496
Methodology: https://510kreport.com/methodology