ZEISS OPMI L STEREO-LAPAROSCOPE— 510(k) K931478

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K931478 for ZEISS OPMI L STEREO-LAPAROSCOPE, Substantially Equivalent on 1994-09-28. Applicant: Carl Zeiss, Inc..

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1993-03-24
Decision date: 1994-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

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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.