KSEA BIPOLAR COAGULATING ELECTRODES— 510(k) K001630

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K001630 for KSEA BIPOLAR COAGULATING ELECTRODES, Substantially Equivalent on 2000-07-19. Applicant: Karl Storz Endoscopy. Device class: 2.

Clearance details

Applicant
Karl Storz Endoscopy
Product code
Code GWG
Device class
Class 2
Regulation
21 CFR 882.1480
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GWG

product code GWG
Death
5
Total
5

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.