# K181173: ELMED Laparoscopic Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Elmed Incorporated
- Decided: Mar 22, 2019 after 324 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990785 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990785: Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments, Jakoubek Medizintechnik GmbH (1999) Summary page 4.
- K051610: Hans Hermann Laparoscopes and Accessories, Hans Hermann GmbH (2005) Summary page 4.

## Indications for use
The ELMED Laparoscopic Instruments are intended for use in a variety of laparoscopic/endoscopic, therapeutic and minimally invasive general surgical procedures for grasping, dissecting, manipulating, retracting, cutting, suturing, occluding or clamping soft tissue. The Laparoscopic Electrodes are electrosurgical devices intended to be used for a variety of general laparoscopic procedures through a port, for coagulation and transection of soft tissue by use of high frequency electric current. Manually operated surgical instruments are available with or without monopolar high frequency connection and are designed to be used through an opening maintained by a cannula which allows inserting and removal of the instrument(s) without damaging the tissue(s). Bipolar Forceps are designed to grasp, manipulate and coagulate selected soft tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Suction/ Irrigation Cannulas have an application(s) in laparoscopic procedures such as gynecologic, general, thoracic and urology and are intended to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization. Trocars and Trocar Sleeves are intended to create portals into an operative site for the direct visualization and/or inserting of other surgical instruments. Needle holders are intended to grasp and manipulate needles inside the peritoneal cavity enabling a surgeon to suture internal soft tissue during a laparoscopic procedure. Instruments should be used only by personnel completely familiar with their operation.

Source page: https://510kreport.com/device/K181173
Methodology: https://510kreport.com/methodology