KSEA UNIMAT 45— 510(k) K981703

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K981703 for KSEA UNIMAT 45, Substantially Equivalent on 1998-08-12. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1998-05-14
Decision date: 1998-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.