CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS— 510(k) K944270

Substantially Equivalent

Chirurgische Instrumente

FDA 510(k) clearance K944270 for CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS, Substantially Equivalent on 1995-07-25. Applicant: Chirurgische Instrumente.

Clearance details

Applicant: Chirurgische Instrumente
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-09-01
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Balgheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.