KSEA BIPOLAR GOAGULATING FORCEPS— 510(k) K962396

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K962396 for KSEA BIPOLAR GOAGULATING FORCEPS, Substantially Equivalent on 1996-08-27. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Code EOB
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 EOB

product code EOB
Malfunction
6,143
Total
6,143

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.