N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE— 510(k) K980623

Substantially Equivalent

N-Tech Endoscopy, Inc.

FDA 510(k) clearance K980623 for N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE, Substantially Equivalent on 1998-04-30. Applicant: N-Tech Endoscopy, Inc..

Clearance details

Applicant: N-Tech Endoscopy, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1998-02-17
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.