Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K231471Substantially equivalent (SESE) · 2023-09-08clearance family
Predicate lineage
- K231471
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
Similar devices
- 2-piece valve kit (Suction and Air/Water Valve) GA Health Company Limited
- 3-Piece Valve Kit Micro-tech Usa
- 3-piece valve kit (Suction, Air/Water and Biopsy Valves) GA Health Company Limited
- 4-Piece Valve Kit Micro-tech Usa
- 4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector) GA Health Company Limited
- A/W Channel Cleaning Adapter + 4-Piece Valve Kit Micro-tech Usa
- AUXILIARY WATER TUBE OLYMPUS MEDICAL SYSTEMS CORP.
- Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit GA Health Company Limited
- Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit GA Health Company Limited
- Air Water Channel Cleaning Adapter + Champion 4-piece Valve Kit GA Health Company Limited
- Air/Water Bottle CO2 Tubing Micro-tech Usa
- Air/Water Bottle CO2 Tubing Micro-tech Usa
Select up to two to place side-by-side with this device.