# K031895: Ksea Opserver Lap

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Sep 23, 2003 after 96 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) XENON 300: named in the summary without a submission number
- (no number) Video Camera: named in the summary without a submission number
- (no number) Thermoflator®: named in the summary without a submission number
- (no number) Unidrive® II: named in the summary without a submission number
- (no number) Autocon® II 400: named in the summary without a submission number
- (no number) Laparomat®: named in the summary without a submission number
- (no number) Quadro Switch: named in the summary without a submission number

## Indications for use
The OPserver LAP is an integral combination unit comprised of the following legally marketed Karl Storz equipment intended for use in laparoscopic surgeries: XENON 300, Video Camera, THERMOFLATOR®, UNIDRIVE® II, AUTOCON?® 11 400, LAPAROMAT?®, and QUADRO SWITCH. The XENON 300 is a 300 watt short arc Xenon lamp light source designed to supply light for endoscopic diagnostic and surgical procedures. The Video Camera is a camera system designed for use in laparoscopic surgeries. The TRICAM®/TELECAM® camera head is suitable for attachment to any rigid or flexible endoscope. The THERMOFLATOR® is a gas insufflator designed for laparoscopic surgical and diagnostic procedures. The device is designed to carefully deliver large flow rates for rapid insufflation, and to monitor the amounts of CO, gas needed to establish and maintain proper distention of the peritoneal cavity. The UNIDRIVE® 1I is the control unit that operates the motorized handles during endoscopic surgical procedures. The AUTOCON® 1I 400 is an electrosurgical generator that is intended for use by qualified surgeons to provide a high frequency (HF) electrical current for cutting and coagulating tissue during endoscopic surgeries. The LAPAROMAT® is a high-capacity suction/irrigation device for use by qualified surgeons to infuse and aspirate sterile irrigation solutions into the peritoneal cavity to rinse or remove carbon deposits, blood clots, or excised tissue during laparoscopic and pelviscopic surgical procedures. The QUADRO SWITCH, in conjunction with its associated handpiece or footswitch, functions as a suction/irrigation control switch device that controls the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.

Source page: https://510kreport.com/device/K031895
Methodology: https://510kreport.com/methodology