DeviceClearance

Image1 S CCU, Image1 S 4U Camera Head— 510(k) K201135

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K201135 for Image1 S CCU, Image1 S 4U Camera Head, Substantially Equivalent on 2020-09-01. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Code FET
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FET

product code FET
Injury
313
Malfunction
54,276
Total
54,589

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.