# K024251: Sightfix

- Pathway: 510(k) (Traditional)
- Applicant: World of Medicine Lemke GmbH
- Decided: Mar 18, 2003 after 85 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 K935279 (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)
- K982013: MGB Lapalux Telescope, Mgb Endoskopische Gerate GmbH (1998) Summary page 1.
- K893121: Robotrac (TM) Retractor Arm, Aesculap Instruments Corp. (1989) Summary page 1.
- K990334: Ksea Endoscope Holder, KARL STORZ Endoscopy-America, Inc. (1999) Summary page 1.

## Indications for use
The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

Source page: https://510kreport.com/device/K024251
Methodology: https://510kreport.com/methodology