DeviceClearance

EXEL Disposable Syringe +3 more— 510(k) K251089

Substantially Equivalent

Exelint International, Co.

FDA 510(k) clearance K251089 for EXEL Disposable Syringe +3 more, Substantially Equivalent on 2025-12-12. Applicant: Exelint International, Co.. Device class: 2.

Clearance details

Device name as filed
EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
Applicant
Exelint International, Co.
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
Redondo Beach, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FMF

view all

More clearances from Exelint International, Co.

view all

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 →

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