MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000— 510(k) K912265

Name: FDA 510(k) clearance K912265
Creator: U.S. Food and Drug Administration
Published: 1991-10-10

Substantially Equivalent

Medical Laser, Inc.

FDA 510(k) clearance K912265 for MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000, Substantially Equivalent on 1991-10-10. Applicant: Medical Laser, Inc.. Device class: 2.

Clearance details

Applicant: Medical Laser, Inc.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-05-22
Decision date: 1991-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K912089 — MODIFIED SERIES 2100 ENDOSCOPES1991-08-12
K901464 — MEDILASE SERIES 2200 ENDOSCOPE1990-08-07
K900894 — MEDILASE SERIES 2100 ENDOSCOPE1990-06-22

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.