KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE— 510(k) K880850

Name: FDA 510(k) clearance K880850
Creator: U.S. Food and Drug Administration
Published: 1988-05-26

Substantially Equivalent

Kmb Medical Products Co.

FDA 510(k) clearance K880850 for KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE, Substantially Equivalent on 1988-05-26. Applicant: Kmb Medical Products Co.. Device class: 2.

Clearance details

Applicant: Kmb Medical Products Co.
Product code: Code FEG
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1988-03-01
Decision date: 1988-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FEG

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K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set2017-08-01
K132314 — MEDLINE ANTI-REFLUX VALVE2013-09-18
K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR2006-01-06
K040388 — NEXT GENERATION SALEM SUMP2004-05-17
K971354 — KNOTT NG TUBE1997-11-19

Adverse events under product code FEG

product code FEG

Death: 2
Total: 2

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 →

Recalls naming K880850

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K880850.

Data sourced from openFDA. This site is unofficial and independent of the FDA.