Cleared Traditional

K982667 - MICROMEDICS NASAL SEPTAL BUTTON

K982667 · Micromedics, Inc. · Ear, Nose, Throat device
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Nov 1998
Decision
116d
Days
-
Risk

K982667 is an FDA 510(k) clearance for the MICROMEDICS NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 24, 1998 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

FDA 510(k) Submission Details - K982667

510(k) Number K982667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date November 24, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 90d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

LFB Device Classification - Class 0,

Product Code LFB Button, Nasal Septal
Device Class -

Regulatory Peers - LFB Button, Nasal Septal

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