TROCAR (FALLER STYLET)— 510(k) K910786

Substantially Equivalent

Accurate Surgical Instruments Co.

FDA 510(k) clearance K910786 for TROCAR (FALLER STYLET), Substantially Equivalent on 1991-09-19. Applicant: Accurate Surgical Instruments Co..

Clearance details

Applicant: Accurate Surgical Instruments Co.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1991-02-25
Decision date: 1991-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto Canado M5v 1y9, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.