510(k) · Cleared
ClearedKsea Opserver Lap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Sep 23, 2003 after a 96-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 23, 2003
- Review
- 96 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | XENON 300 Named without a submission number | |
| * | — | Video Camera Named without a submission number | |
| * | — | Thermoflator® Named without a submission number | |
| * | — | Unidrive® II Named without a submission number | |
| * | — | Autocon® II 400 Named without a submission number | |
| * | — | Laparomat® Named without a submission number | |
| * | — | Quadro Switch Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
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…
Read the full statement (258 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K031895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031895: Ksea Opserver Lap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031895
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026