Cleared Traditional

ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (K881507) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881507 · Hgm Medical Laser Systems, Inc. · Obstetrics & Gynecology device
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Apr 1989
Decision
381d
Days
Class 2
Risk

K881507 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - the FDA obstetrics and gynecology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hgm Medical Laser Systems, Inc. devices

Submission Details

510(k) Number K881507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1988
Decision Date April 27, 1989
Days to Decision 381 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 160d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
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 Obstetrics & Gynecology devices follow this clearance model.