# K014158: Endoscopic Camera TC804/C4

- Pathway: 510(k) (Traditional)
- Applicant: World of Medicine Lemke GmbH
- Decided: Mar 14, 2002 after 85 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914883 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950862: Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures, Karl Storz Imaging, Inc. (1995) Summary page 1.
- K914883: Circon Acmi Gen Surg Instru for Mini Invasive Surg, Circon Video (1993) Summary page 1.
- K983567: Image Technologies Stericam, Coupler-Drape and Troview Imaging System, Med Images, Inc. (1999) Summary page 1.

## Most influential descendants
- K032544: VP-1000; Med Cam 100; VP-3000A; Med Cam 300 (2003), 0 descendants of its own

## Recalls of this device
- Sep 23, 2011 · Not classified · Z-0082-2012: HD1200 camera heads may cause image issues

## Indications for use
The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

Source page: https://510kreport.com/device/K014158
Methodology: https://510kreport.com/methodology