APPLICATOR TIP/DUAL SPRAYER KIT— 510(k) K010708

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K010708 for APPLICATOR TIP/DUAL SPRAYER KIT, Substantially Equivalent on 2001-04-30. Applicant: Interpore Cross Intl..

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2001-03-09
Decision date: 2001-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.