EMODREN EXCHANGEABLE PLASTIC BELLOWS— 510(k) K853295

Name: FDA 510(k) clearance K853295
Creator: U.S. Food and Drug Administration
Published: 1985-08-20

Substantially Equivalent

Parexel Intl. Corp.

FDA 510(k) clearance K853295 for EMODREN EXCHANGEABLE PLASTIC BELLOWS, Substantially Equivalent on 1985-08-20. Applicant: Parexel Intl. Corp.. Device class: 1.

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1985-08-06
Decision date: 1985-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.