KEYMED SIGMOIDOSCOPE SUCTION UNIT— 510(k) K841822

Substantially Equivalent

Keymed, Inc.

FDA 510(k) clearance K841822 for KEYMED SIGMOIDOSCOPE SUCTION UNIT, Substantially Equivalent on 1984-07-27. Applicant: Keymed, Inc..

Clearance details

Applicant: Keymed, Inc.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 1984-05-02
Decision date: 1984-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.