Moss Gastrostomy Tube, Moss Nasal Tube Mark IV— 510(k) K190414

Substantially Equivalent

Moss Tubes, Inc.

FDA 510(k) clearance K190414 for Moss Gastrostomy Tube, Moss Nasal Tube Mark IV, Substantially Equivalent on 2019-06-14. Applicant: Moss Tubes, Inc..

Clearance details

Applicant: Moss Tubes, Inc.
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2019-02-21
Decision date: 2019-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Castleton On Hudson, NY, US

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Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

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.