Cleared Traditional

K870773 - ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K870773 · Hgm, Inc. · Neurology device
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Jul 1987
Decision
134d
Days
Class 3
Risk

K870773 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER. Classified as Laser, Neurosurgical, Argon (product code LLF), Class III - Premarket Approval.

Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 10, 1987 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Neurology 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hgm, Inc. devices

Submission Details

510(k) Number K870773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1987
Decision Date July 10, 1987
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 148d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLF Laser, Neurosurgical, Argon
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.