Cleared Traditional

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

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010213 · Uromed Corp. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Apr 2001
Decision
87d
Days
Class 2
Risk

K010213 is an FDA 510(k) clearance for the MODIFICATION TO CAVERMAP SURGICAL AID. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Uromed Corp. (Norwood, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Uromed Corp. devices

Submission Details

510(k) Number K010213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K010213.
Evala Nerve Stimulator (EPNR002)
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K232888 · Suzhou Haishen Medical Device Associates Co., Ltd. · Dec 2023