ROSS ENTERAL FEEDING TUBE— 510(k) K972437

Name: FDA 510(k) clearance K972437
Creator: U.S. Food and Drug Administration
Published: 1998-01-26

Substantially Equivalent

Ross Products

FDA 510(k) clearance K972437 for ROSS ENTERAL FEEDING TUBE, Substantially Equivalent on 1998-01-26. Applicant: Ross Products. Device class: 2.

Clearance details

Applicant: Ross Products
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1997-06-30
Decision date: 1998-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18

More clearances from Ross Products

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K011467 — ROSS EMBRACE PUMP SET2001-08-10
K950017 — FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM1997-03-14
K951429 — FLEXIFLO 6.1 ENTERAL NUTRITION PUMP1995-12-22

Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.