# K060233: Trokamed GMBH Endoscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Trokamed GmbH
- Decided: Jul 19, 2006 after 170 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: 2 generations back to K932540 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991718: Operating Laparoscope, 10-5 MM, Angeled, Operating Laparoscope 12-7MM, Angled, Operating Laparoscope, 10-5,,. Oblique, D, Richard Wolf Medical Instruments Corp. (1999) Summary page 2.
- K051610: Hans Hermann Laparoscopes and Accessories, Hans Hermann GmbH (2005) Summary page 2.
- K974382: Ackermann Surgical Instruments, Ackermann Instrumente GmbH (1998) Summary page 2.

## Indications for use
The laparoscopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures. The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpel tunnel syndrome), temporal mandibular joint, ankle and elbow. The cystoscopes and accessories are used for visualizing body cavities end organs (via natural passages). For examination, diagnosis and for therapy in conjunction with endoscopic accessories / auxiliary instruments through the scope's working channel. The instruments are reusable; they are intended to be cleaned, sterilized and reused.

Source page: https://510kreport.com/device/K060233
Methodology: https://510kreport.com/methodology