STERILE SALINE - FOR SUCTION CATHETER LUBRICATION— 510(k) K895039

Name: FDA 510(k) clearance K895039
Creator: U.S. Food and Drug Administration
Published: 1989-10-03

Substantially Equivalent

Aplicare, Inc.

FDA 510(k) clearance K895039 for STERILE SALINE - FOR SUCTION CATHETER LUBRICATION, Substantially Equivalent on 1989-10-03. Applicant: Aplicare, Inc.. Device class: 2.

Clearance details

Applicant: Aplicare, Inc.
Product code: Code GCX
Device class: Class 2
Regulation: 21 CFR 880.6740
Advisory panel: General Hospital
Date received: 1989-08-09
Decision date: 1989-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aplicare, Inc.

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K873563 — APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY1987-11-23
K861557 — APLICARE SKIN PROTECTANT PREP PAD1986-07-11
K861558 — APLICARE SKIN PROTECTANT SWABSTICK1986-06-04
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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.