Cleared Traditional

K852913 - HGM ENDOCOAGULATOR MODEL 20 (FDA 510(k) Clearance)

K852913 · Hgm, Inc. · Gastroenterology & Urology device
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Sep 1985
Decision
56d
Days
-
Risk

K852913 is an FDA 510(k) clearance for the HGM ENDOCOAGULATOR MODEL 20.

Submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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: 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 Hgm, Inc. devices

Submission Details

510(k) Number K852913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date September 05, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -