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)K213978Substantially equivalent (SESE) · 2022-10-18clearance family
Predicate lineage
- K213978
Cited as predicate by: K223108
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
- 0 Deg 4mm AC Arthroscope Poc
- 1.2mm InnerVue II Scope Kit BIOVISION TECHNOLOGIES, LLC
- 1.9mm Arthroscope, 30°, Autoclavable Nexus Cmf, L.L.C.
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 10K/24K Conmed Corporation
- 24K Conmed Corporation
Select up to two to place side-by-side with this device.