PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE— 510(k) K100546

Substantially Equivalent

Parkermedicalinc

FDA 510(k) clearance K100546 for PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE, Substantially Equivalent on 2010-06-03. Applicant: Parkermedicalinc.

Clearance details

Applicant: Parkermedicalinc
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2010-02-25
Decision date: 2010-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.