DeviceClearance

3&4 WAY PLASTIC STOPCOCKS, NONSTERILE— 510(k) K792125

Substantially Equivalent

Tronomed, Inc.

FDA 510(k) clearance K792125 for 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE, Substantially Equivalent on 1980-01-16. Applicant: Tronomed, Inc.. Device class: 2.

Clearance details

Applicant
Tronomed, 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
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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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 K792125

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 K792125.

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