DeviceClearance

NBS CONNECTING TUBE SET— 510(k) K001068

Substantially Equivalent

Nbs Products CO

FDA 510(k) clearance K001068 for NBS CONNECTING TUBE SET, Substantially Equivalent on 2000-06-14. Applicant: Nbs Products CO. Device class: 2.

Clearance details

Applicant
Nbs Products CO
Product code
Code HIF
Device class
Class 2
Regulation
21 CFR 884.1730
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Brunswick, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HIF

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Adverse events under product code HIF

product code HIF
Death
19
Injury
578
Malfunction
5,639
Total
6,236

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 K001068

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 K001068.

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