MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP— 510(k) K070814

Substantially Equivalent

Confluent Surgical,Inc

FDA 510(k) clearance K070814 for MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, Substantially Equivalent on 2007-05-30. Applicant: Confluent Surgical,Inc.

Clearance details

Applicant: Confluent Surgical,Inc
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2007-03-26
Decision date: 2007-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.