DeviceClearance

STOPCOCK & LUER LOCK PLUG— 510(k) K954970

Substantially Equivalent

Medex, Inc.

FDA 510(k) clearance K954970 for STOPCOCK & LUER LOCK PLUG, Substantially Equivalent on 1996-04-22. Applicant: Medex, Inc.. Device class: 2.

Clearance details

Applicant
Medex, Inc.
Product code
Code FMG
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dublin, OH, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FMG

view all

More clearances from Medex, Inc.

view all

Adverse events under product code FMG

product code FMG
Death
14
Malfunction
3,433
Other
1
Total
3,448

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 K954970

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 K954970.

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