DeviceClearance

MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)— 510(k) K131641

Substantially Equivalent

Nipro Medical Corporation

FDA 510(k) clearance K131641 for MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP), Substantially Equivalent on 2013-08-28. Applicant: Nipro Medical Corporation. Device class: 2.

Clearance details

Applicant
Nipro Medical Corporation
Product code
Code FMF
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FMF

product code FMF
Death
15
Injury
2,263
Malfunction
29,722
Other
17
Total
32,017

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 K131641

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 K131641.

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