DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER— 510(k) K014248

Name: FDA 510(k) clearance K014248
Creator: U.S. Food and Drug Administration
Published: 2002-03-21

Substantially Equivalent

Urogyn , Ltd.

FDA 510(k) clearance K014248 for DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER, Substantially Equivalent on 2002-03-21. Applicant: Urogyn , Ltd.. Device class: 2.

Clearance details

Applicant: Urogyn , Ltd.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2001-12-26
Decision date: 2002-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

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