KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM— 510(k) K071530

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K071530 for KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM, Substantially Equivalent on 2007-08-24. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Code EOQ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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.