EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000— 510(k) K873489

Name: FDA 510(k) clearance K873489
Creator: U.S. Food and Drug Administration
Published: 1987-12-29

Substantially Equivalent

J. H. Emerson Co.

FDA 510(k) clearance K873489 for EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000, Substantially Equivalent on 1987-12-29. Applicant: J. H. Emerson Co.. Device class: 2.

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1987-08-31
Decision date: 1987-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA1992-11-17
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Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.