# K132015: Truclear Morcellation System and Truclear Morcellators

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 13, 2013 after 165 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953695 (1995). 7 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110038: Truclear Morcellator System, Smith & Nephew, Inc. (2011) Summary page 1.
- K103389: Truclear Incisor Plus Blade 2.9, Smith & Nephew, Inc. (2011) Summary page 1.
- K041774: Iur Reciprocating Morcellator Model # 7210517, Smith & Nephew, Inc. (2004) Summary page 1.
- K031787: Smith & Nephew Iur Morcellation System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K173901: MyoSure MANUAL Tissue Removal Device (2018), 4 descendants of its own

## Recalls of this device
- Jun 7, 2022 · Class II · Z-1467-2022: Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

## Indications for use
The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

Source page: https://510kreport.com/device/K132015
Methodology: https://510kreport.com/methodology