Cleared Traditional

K972317 - MONTGOMERY THYROPLASTY IMPLANT SYSTEM

K972317 is an FDA 510(k) clearance for MONTGOMERY THYROPLASTY IMPLANT SYSTEM, manufactured by Boston Medical Products, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code MIX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972317 · Boston Medical Products, Inc. · Ear, Nose, Throat device
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Sep 1997
Decision
90d
Days
Class 2
Risk

K972317 is an FDA 510(k) clearance for the MONTGOMERY THYROPLASTY IMPLANT SYSTEM. Classified as System, Vocal Cord Medialization (product code MIX), Class II - Special Controls.

Submitted by Boston Medical Products, Inc. (North Attleboro, US). The FDA issued a Cleared decision on September 18, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - 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: 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K972317

510(k) Number K972317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date September 18, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 89d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIX Device Classification - Class 2, Special Controls

Product Code MIX System, Vocal Cord Medialization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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.