DeviceClearance

J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA— 510(k) K110883

Substantially Equivalent

Busse Hospital Disposables

FDA 510(k) clearance K110883 for J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA, Substantially Equivalent on 2011-06-08. Applicant: Busse Hospital Disposables. Device class: 2.

Clearance details

Applicant
Busse Hospital Disposables
Product code
Code KNW
Device class
Class 2
Regulation
21 CFR 876.1075
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hauppauge, NY, US
Download summary PDFView on FDA.gov ↗

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More clearances from Busse Hospital Disposables

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Adverse events under product code KNW

product code KNW
Death
9
Injury
965
Malfunction
10,444
Other
3
Total
11,421

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 K110883

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 K110883.

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