RUSCH ENTERAL FEEDING TUBE— 510(k) K963779

Name: FDA 510(k) clearance K963779
Creator: U.S. Food and Drug Administration
Published: 1997-05-23

Substantially Equivalent

Rusch, Inc.

FDA 510(k) clearance K963779 for RUSCH ENTERAL FEEDING TUBE, Substantially Equivalent on 1997-05-23. Applicant: Rusch, Inc.. Device class: 2.

Clearance details

Applicant: Rusch, Inc.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1996-09-20
Decision date: 1997-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, 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 Rusch, Inc.

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K010420 — RUSCH MMG/O'NEIL CATHETER2001-05-09
K993528 — RUSCH EMERGENCY MASK2000-05-31
K993194 — RUSCH MANUAL RESUSCITATOR BAG2000-03-24
K980870 — RUSCH SILICONE FOLEY CATHETER1998-06-09
K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER1998-01-27

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.