Cleared Traditional

K871424 - ENDOCOAGULATOR MODEL 5

K871424 is an FDA 510(k) clearance for ENDOCOAGULATOR MODEL 5, manufactured by Hgm, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code LMS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K871424 · Hgm, Inc. · Ear, Nose, Throat device
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Jul 1987
Decision
90d
Days
Class 2
Risk

K871424 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER. Classified as Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology (product code LMS), Class II - Special Controls.

Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 8, 1987 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 874.4490 - 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 Hgm, Inc. devices

FDA 510(k) Submission Details - K871424

510(k) Number K871424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1987
Decision Date July 08, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
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.

LMS Device Classification - Class 2, Special Controls

Product Code LMS Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4490
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.