LAPAROSCOPIC SUCTION/IRRIGATION PROBE— 510(k) K920643

Name: FDA 510(k) clearance K920643
Creator: U.S. Food and Drug Administration
Published: 1992-05-06

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K920643 for LAPAROSCOPIC SUCTION/IRRIGATION PROBE, Substantially Equivalent on 1992-05-06. Applicant: O.R. Concepts, Inc.. Device class: 1.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-02-12
Decision date: 1992-05-06
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 GBZ

product code GBZ

Death: 2
Total: 2

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.