VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,— 510(k) K100533

Substantially Equivalent

Vibrynt, Inc.

FDA 510(k) clearance K100533 for VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,, Substantially Equivalent on 2011-02-08. Applicant: Vibrynt, Inc..

Clearance details

Applicant: Vibrynt, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2010-02-25
Decision date: 2011-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, 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.