PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2— 510(k) K083275

Name: FDA 510(k) clearance K083275
Creator: U.S. Food and Drug Administration
Published: 2009-06-09

Substantially Equivalent

Max Endoscopy, Inc.

FDA 510(k) clearance K083275 for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2, Substantially Equivalent on 2009-06-09. Applicant: Max Endoscopy, Inc.. Device class: 2.

Clearance details

Applicant: Max Endoscopy, Inc.
Product code: Code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2008-11-06
Decision date: 2009-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Macedonia, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.