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

Name: FDA 510(k) clearance K190414
Creator: U.S. Food and Drug Administration
Published: 2019-06-14

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.. Device class: 2.

Clearance details

Applicant: Moss Tubes, Inc.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
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

Download summary PDF View on FDA.gov ↗

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More clearances from Moss Tubes, Inc.

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K990389 — MOSS GASTROSTOMY TUBE1999-03-22
K984628 — MODIFICATION OF MOSS P.E.G. TRAY1999-03-17
K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV1999-03-02
K984310 — MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE1999-02-24

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.