COLONOSCOPE/SIGMOIDOSCOPE SHEATHES— 510(k) K100966

Name: FDA 510(k) clearance K100966
Creator: U.S. Food and Drug Administration
Published: 2010-08-03

Substantially Equivalent

Sheathing Technologies, Inc.

FDA 510(k) clearance K100966 for COLONOSCOPE/SIGMOIDOSCOPE SHEATHES, Substantially Equivalent on 2010-08-03. Applicant: Sheathing Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Sheathing Technologies, Inc.
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-04-08
Decision date: 2010-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgan Hill, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.