CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)— 510(k) K962255

Substantially Equivalent

Clarus Medical Systems, Inc.

FDA 510(k) clearance K962255 for CLARUS MURPHYPEN ENDOSCOPE(2127-XXX), Substantially Equivalent on 1996-09-11. Applicant: Clarus Medical Systems, Inc..

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1996-06-12
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.