DeviceClearance

PENCIL POINT NEEDLE— 510(k) K041843

Substantially Equivalent

Epimed International, Inc.

FDA 510(k) clearance K041843 for PENCIL POINT NEEDLE, Substantially Equivalent on 2004-08-24. Applicant: Epimed International, Inc.. Device class: 2.

Clearance details

Applicant
Epimed International, Inc.
Product code
Code BSP
Device class
Class 2
Regulation
21 CFR 868.5150
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Johnstown, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BSP

product code BSP
Death
2
Total
2

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 K041843

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 K041843.

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