# K040855: Instrumed Laparoscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed International, Inc.
- Decided: Apr 16, 2004 after 14 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: 1 generation back to K012660 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012660: Gimmi'alpha' Endoscopes & Accessories, Gimmi GmbH (2001) Summary page 1.

## Most influential descendants
- K080051: Virtual Ports Endoclear System (2008), 1 descendant of its own
- K100346: Endoclear System (2010), 0 descendants of its own

## Indications for use
Instrumed Laparoscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.

Source page: https://510kreport.com/device/K040855
Methodology: https://510kreport.com/methodology