DeviceClearance

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000— 510(k) K071482

Substantially Equivalent

Synergetics, Inc.

FDA 510(k) clearance K071482 for STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000, Substantially Equivalent on 2007-12-20. Applicant: Synergetics, Inc.. Device class: 2.

Clearance details

Applicant
Synergetics, Inc.
Product code
Code GXD
Device class
Class 2
Regulation
21 CFR 882.4400
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
O' Fallon, MO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GXD

product code GXD
Injury
228
Total
228

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 K071482

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 K071482.

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