DeviceClearance

STRYKER QUIKFLAP STERILE PROCEDURE PACK— 510(k) K120352

Substantially Equivalent

Stryker

FDA 510(k) clearance K120352 for STRYKER QUIKFLAP STERILE PROCEDURE PACK, Substantially Equivalent on 2012-06-11. Applicant: Stryker. Device class: 2.

Clearance details

Applicant
Stryker
Product code
Code GWO
Device class
Class 2
Regulation
21 CFR 882.5320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Porage, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GWO

product code GWO
Malfunction
583
Total
583

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 K120352

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 K120352.

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