VALVED SURGICAL ASPIRATORS— 510(k) K813029

Name: FDA 510(k) clearance K813029
Creator: U.S. Food and Drug Administration
Published: 1981-12-14

Substantially Equivalent

Imedix

FDA 510(k) clearance K813029 for VALVED SURGICAL ASPIRATORS, Substantially Equivalent on 1981-12-14. Applicant: Imedix. Device class: 2.

Clearance details

Applicant: Imedix
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1981-10-28
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCX

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K042454 — STRYKER CASSETTE PUMP2004-12-09
K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM1999-08-03
K972074 — SUCTION INSTRUMENTATION1997-07-25
K971022 — CHASE SUCKER1997-04-17
K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE1996-12-31

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.