MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM— 510(k) K032820

Name: FDA 510(k) clearance K032820
Creator: U.S. Food and Drug Administration
Published: 2003-10-23

Substantially Equivalent

Ndo Surgical, Inc.

FDA 510(k) clearance K032820 for MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM, Substantially Equivalent on 2003-10-23. Applicant: Ndo Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Ndo Surgical, Inc.
Product code: Code ODE
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-10
Decision date: 2003-10-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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