ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR— 510(k) K071553

Name: FDA 510(k) clearance K071553
Creator: U.S. Food and Drug Administration
Published: 2007-09-18

Substantially Equivalent

Ndo Surgical, Inc.

FDA 510(k) clearance K071553 for ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR, Substantially Equivalent on 2007-09-18. 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: 2007-06-06
Decision date: 2007-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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