# K031787: Smith & Nephew Iur Morcellation System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 2, 2003 after 175 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: 1 generation back to K953695 (1995). 3 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu, Gynecare Innovation Center (1997) Summary page 1.
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.
- K954989: Dyonics Disposable Endoscopic Surgery Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.

## Most influential descendants
- K041774: Iur Reciprocating Morcellator Model # 7210517 (2004), 34 descendants of its own
- K110038: Truclear Morcellator System (2011), 25 descendants of its own
- K103389: Truclear Incisor Plus Blade 2.9 (2011), 25 descendants of its own
- 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

## 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 Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.

Source page: https://510kreport.com/device/K031787
Methodology: https://510kreport.com/methodology