DeviceClearance

ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE— 510(k) K020220

Substantially Equivalent

Synergetics, Inc.

FDA 510(k) clearance K020220 for ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE, Substantially Equivalent on 2002-08-23. Applicant: Synergetics, Inc.. Device class: Unclassified.

Clearance details

Applicant
Synergetics, Inc.
Product code
Code LFL
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Charles, MO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LFL

product code LFL
Death
29
Injury
1,046
Malfunction
21,642
Total
22,717

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 K020220

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 K020220.

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