MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE— 510(k) K913104

Substantially Equivalent

Dexide, Inc.

FDA 510(k) clearance K913104 for MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE, Substantially Equivalent on 1991-07-31. Applicant: Dexide, Inc..

Clearance details

Applicant: Dexide, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1991-07-12
Decision date: 1991-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.