NTECH CYSTOSCOPES— 510(k) K980592

Substantially Equivalent

N-Tech Endoscopy, Inc.

FDA 510(k) clearance K980592 for NTECH CYSTOSCOPES, Substantially Equivalent on 1998-04-28. Applicant: N-Tech Endoscopy, Inc..

Clearance details

Applicant: N-Tech Endoscopy, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-17
Decision date: 1998-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.