MODIFICATION TO CAVERMAP SURGICAL AID— 510(k) K010098

Name: FDA 510(k) clearance K010098
Creator: U.S. Food and Drug Administration
Published: 2001-02-01

Substantially Equivalent

Uromed Corp.

FDA 510(k) clearance K010098 for MODIFICATION TO CAVERMAP SURGICAL AID, Substantially Equivalent on 2001-02-01. Applicant: Uromed Corp.. Device class: 1.

Clearance details

Applicant: Uromed Corp.
Product code: Code FGM
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 2001-01-11
Decision date: 2001-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.