# K103389: Truclear Incisor Plus Blade 2.9

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 25, 2011 after 127 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 K953695 (1995). 4 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031787: Smith & Nephew Iur Morcellation System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K132015: Truclear Morcellation System and Truclear Morcellators (2013), 24 descendants of its own
- K142029: Myosure Hysteroscopic Tissue Removal System (2014), 14 descendants of its own
- K152723: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (2015), 6 descendants of its own
- K172566: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices (2017), 5 descendants of its own
- K190372: Aveta System (2019), 4 descendants of its own

## Indications for use
The TRUGLEARTM Incisor® Plus Blade 2.9 is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endomeirial tissue for the following indications, submucous myomas and endometrial polyps. The TRUCLEARTM Incisor®I Plus Blade 2.9 is used specifically with the TRUCLEAR Hysteroscopic Morcellator. The TRUCLEAR Hysteroseopic Morcellator includes: " TRUCLEAR Control Unit * TRUCLEAR Footswitch * TRUCLEAR Handpiece

Source page: https://510kreport.com/device/K103389
Methodology: https://510kreport.com/methodology