STORZ SLX-F2 STORM TOUCH— 510(k) K070579

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K070579 for STORZ SLX-F2 STORM TOUCH, Substantially Equivalent on 2007-08-30. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Code LNS
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Culver City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LNS

product code LNS
Death
4
Injury
320
Total
324

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 →

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