# K024304: Microsurgical Bipolar Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Neomedix Corp.
- Decided: Feb 25, 2003 after 63 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K792365 (1979). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010487: Bipolar Pencil, Model 3901-002, 3900-002, Medtronic PS Medical (2001) Summary page 1.
- K962678: Bipolar Pencil Coagulator, Kirwan Surgical Products, Inc. (1996) Summary page 1.
- K993655: Micro-France Electrosurgical Instruments, Various, Xomed, Inc. (1999) Summary page 1.
- K991218: Oratec Bipolar Ablation Probes, Oratec Interventions, Inc. (1999) Summary page 1.
- K971538: Mentor Gemini Hemostatic Eraser, Mentor Ophthalmics, Inc. (1997) Summary page 1.
- K952151: Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204), Storz (1996) Summary page 1.
- K003587: Clearglide Precision Bipolar Device, ETHICON, Inc. (2000) Summary page 1.
- K002000: Multifuction Suction Irrigation System, Existing of Suction Irrigation Handles, Suction Irrigation Tubes, and Tube Sets;, Richard Wolf Medical Instruments Corp. (2001) Summary page 1.

## Most influential descendants
- K040584: NMX-1000 (2004), 1 descendant of its own
- K220891: Kahook Dual Blade Glide (KDB Glide) (2024), 0 descendants of its own

## Indications for use
The NeoMedix MicroSurgical Bipolar Handpiece is to be used in electrosurgical applications where low power radio frequency current is applied through a bipolar probe for the purpose of cutting and coagulation of soft tissues. The Handpiece is intended to be used in general and ophthalmic surgery where low impedance or wet field conditions exist.

Source page: https://510kreport.com/device/K024304
Methodology: https://510kreport.com/methodology