ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS— 510(k) K941494

Substantially Equivalent

Sharpe Endosurgical Corp.

FDA 510(k) clearance K941494 for ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS, Substantially Equivalent on 1994-04-22. Applicant: Sharpe Endosurgical Corp..

Clearance details

Applicant: Sharpe Endosurgical Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-28
Decision date: 1994-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake,, MN, 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.