DeviceClearance

Guarded Luer Connector— 510(k) K173577

Substantially Equivalent

International Medical Industries, Inc.

FDA 510(k) clearance K173577 for Guarded Luer Connector, Substantially Equivalent on 2018-06-07. Applicant: International Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant
International Medical Industries, Inc.
Product code
Code LHI
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pompano Beach, FL, US
Download summary PDFView on FDA.gov ↗

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More clearances from International Medical Industries, Inc.

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Adverse events under product code LHI

product code LHI
Injury
207
Malfunction
7,820
Other
3
Total
8,030

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K173577

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173577.

Data sourced from openFDA. This site is unofficial and independent of the FDA.