DeviceClearance

STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)— 510(k) K954726

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K954726 for STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION), Substantially Equivalent on 1995-11-29. Applicant: Stryker Endoscopy. Device class: 2.

Clearance details

Applicant
Stryker Endoscopy
Product code
Code GCX
Device class
Class 2
Regulation
21 CFR 880.6740
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Clara, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GCX

product code GCX
Death
9
Malfunction
592
Other
2
Total
603

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 K954726

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 K954726.

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