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: K100693, K103793, K121275, K122817, K123219, K143017, K153756, K162508, K183645, K210466
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.
- BIATAIN ADVANCED MEDICAL SOLUTIONS LIMITED
- "ACTICOAT 7 4"" X 5""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT 7 2"" X 2""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT 7 6"" X 6""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 16"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 2"" X 2""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 4""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 48""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 4"" X 8""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX3 8"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX7 16"" X 16""" SMITH & NEPHEW MEDICAL LIMITED
- "ACTICOAT FLEX7 2"" x 2""" SMITH & NEPHEW MEDICAL LIMITED