CANDELA INTRODUCER SHEATH SYSTEM— 510(k) K912443

Name: FDA 510(k) clearance K912443
Creator: U.S. Food and Drug Administration
Published: 1991-08-16

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K912443 for CANDELA INTRODUCER SHEATH SYSTEM, Substantially Equivalent on 1991-08-16. Applicant: Candela Laser Corp.. Device class: 2.

Clearance details

Applicant: Candela Laser Corp.
Product code: Code FDE
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-06-03
Decision date: 1991-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDE

product code FDE

Other: 1
Total: 1

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.