POOLE TIP SUCTION PROBE— 510(k) K915762

Name: FDA 510(k) clearance K915762
Creator: U.S. Food and Drug Administration
Published: 1992-03-13

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K915762 for POOLE TIP SUCTION PROBE, Substantially Equivalent on 1992-03-13. Applicant: O.R. Concepts, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code GCI
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-12-24
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCI

product code GCI

Malfunction: 635
Total: 635

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.