Cleared Traditional

K010213 - MODIFICATION TO CAVERMAP SURGICAL AID
(FDA 510(k) Clearance)

K010213 · Uromed Corp. · Ear, Nose, Throat
Apr 2001
Decision
87d
Days
Class 2
Risk

K010213 is an FDA 510(k) clearance for the MODIFICATION TO CAVERMAP SURGICAL AID, a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Uromed Corp. (Norwood, US). The FDA issued a Cleared decision on April 20, 2001, 87 days after receiving the submission on January 23, 2001. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K010213 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2001
Decision Date April 20, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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