MECONIUM ASPIRATOR— 510(k) K893649

Name: FDA 510(k) clearance K893649
Creator: U.S. Food and Drug Administration
Published: 1989-08-21

Substantially Equivalent

Gish Biomedical, Inc.

FDA 510(k) clearance K893649 for MECONIUM ASPIRATOR, Substantially Equivalent on 1989-08-21. Applicant: Gish Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Gish Biomedical, Inc.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1989-05-15
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCX

view all

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

More clearances from Gish Biomedical, Inc.

view all

K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT2009-09-18
K090450 — MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT2009-09-18
K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 07302009-08-04
K083131 — MEDOS HILITE RESERVOIR, MODEL: 40302009-07-30
K082403 — MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT2009-05-15

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.