# K990785: Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Jakoubek Medizintechnik GmbH
- Decided: Aug 27, 1999 after 171 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K181173: ELMED Laparoscopic Instruments and Accessories (2019), 0 descendants of its own

## Indications for use
Providing thorough irrigation and aspiration of the peritoneal cavity. Bleeders can be identified, bile, stones, tissue, blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry. Sole purpose of these instruments are to move tissue around. They can not grasp or restrain by means of grasping any body organ or tissue. They are introduced into the body cavity through a trocar sleeve. Once introduced they can only move tissue from side to side or up and down. Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct observation and/or dissecting, cutting, repairing, removal or manipulation of internal tissues and/or organs. Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said device. Internal tissues or organs may be visualized for either diagnostic or operative procedures. Verres needles puncture through the abdominal wall to enable the introduction of gases into the abdominal cavity creating space between the fascia and the internal body organs, allowing for the safe introduction of laparoscopic instrumentation into the peritoneal cavity. Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired. Instruments which permit the grasping and manipulation of needles inside the peritoneal cavity enableing a surgeon to suture internal tissues during laparoscopic procedures. Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy, cut, coagulate, manipulate or retrieve internal tissues or organs while performing laparoscopic procedures.

Source page: https://510kreport.com/device/K990785
Methodology: https://510kreport.com/methodology