ADMINISTRATION SET— 510(k) K810131

Name: FDA 510(k) clearance K810131
Creator: U.S. Food and Drug Administration
Published: 1981-02-26

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K810131 for ADMINISTRATION SET, Substantially Equivalent on 1981-02-26. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code FPD
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1981-01-19
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K821159 — IN-LINE OXYGEN MONITORING SYSTEM1982-05-25
K811068 — BYPASS COIL1981-05-27
K811071 — VENOUS OXYGEN PROBE1981-05-05
K803238 — INTRAVASCULAR CATHETER1981-04-23
K810630 — SILICONE ELASTOMER COATED LATEX FOLEY1981-03-31

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.