The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European Union20GA Curved Laser Probe with Alcon adaptorB-08717872013947
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.
No recalls linked.
Predicate lineage
Cited as predicate by: K213467
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.
None in the loaded window.
- 20GA Alcon Illuminating Laser Probe - Alcon Peregrine Surgical, Llc
- 20GA Alcon Illuminating Laser Probe - Iridex Peregrine Surgical, Llc
- 20GA Aspirating Laser Probe, SMA905 Peregrine Surgical, Llc
- 20GA Aspirating Laser Probe, SMA906 Peregrine Surgical, Llc
- 20GA Curved Alcon Illuminating Laser Probe - Alcon Peregrine Surgical, Llc
- 20GA Curved Alcon Illuminating Laser Probe - Iridex Peregrine Surgical, Llc
- 20GA Curved Illuminating Laser Probe - Alcon Peregrine Surgical, Llc
- 20GA Curved Illuminating Laser Probe - Iridex Peregrine Surgical, Llc
- 20GA Curved Illuminating Probe, SMA 905 Peregrine Surgical, Llc
- 20GA Curved Illuminating Probe, SMA905 Peregrine Surgical, Llc
- 20GA Curved Illuminating Probe, SMA905 Peregrine Surgical, Llc
- 20GA Curved Illuminating Probe, SMA906 Peregrine Surgical, Llc