LAPAROSCOPIC SURGICAL INSTRUMENT— 510(k) K953548

Substantially Equivalent

Gabris Surgical Corp.

FDA 510(k) clearance K953548 for LAPAROSCOPIC SURGICAL INSTRUMENT, Substantially Equivalent on 1995-09-19. Applicant: Gabris Surgical Corp..

Clearance details

Applicant: Gabris Surgical Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1995-07-28
Decision date: 1995-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

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.