DeviceClearance

INJECTION NEEDLE— 510(k) K834403

Substantially Equivalent

Bobbs Medical, Inc.

FDA 510(k) clearance K834403 for INJECTION NEEDLE, Substantially Equivalent on 1984-02-04. Applicant: Bobbs Medical, Inc.. Device class: 2.

Clearance details

Applicant
Bobbs Medical, Inc.
Product code
Code FBK
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FBK

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Adverse events under product code FBK

product code FBK
Other
1
Total
1

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 K834403

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 K834403.

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