Cleared Traditional

K971538 - MENTOR GEMINI HEMOSTATIC ERASER

K971538 is an FDA 510(k) clearance for MENTOR GEMINI HEMOSTATIC ERASER, manufactured by Mentor Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HQO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K971538 · Mentor Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
77d
Days
Class 2
Risk

K971538 is an FDA 510(k) clearance for the MENTOR GEMINI HEMOSTATIC ERASER. Classified as Unit, Cautery, Thermal, Ac-powered (product code HQO), Class II - Special Controls.

Submitted by Mentor Ophthalmics, Inc. (Norwell, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4115 - the FDA ophthalmic 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K971538

510(k) Number K971538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date July 14, 1997
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQO Device Classification - Class 2, Special Controls

Product Code HQO Unit, Cautery, Thermal, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4115
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HQO Unit, Cautery, Thermal, Ac-powered

All 9
Devices cleared under the same product code (HQO) and FDA review panel - the closest regulatory comparables to K971538.
STARION UNIVERSAL POWER SUPPLY (UPS)
K043155 · Starion Instruments · Dec 2004
THERMAL CAUTERY UNIT, MODEL 150
K002341 · Geiger Medical Technologies, Inc. · Oct 2000
AC POWERED THERMAL CAUTERY UNIT
K000893 · Starion Instruments · Jun 2000
D.O.R.C. MICRODIATHERMY SYSTEM
K962135 · Dutch Ophthalmic USA, Inc. · Aug 1996
BIPOLAR ELECTROSURGICAL PENCIL
K943031 · Boston Surgical Products, Inc. · Sep 1994
ADLER DISPOSABLE BIPOLAR CORD
K900913 · Adler Instrument Co. · Apr 1990
K971538 · MENTOR GEMINI HEMOSTATIC ERASER
Download PDF FDA Summary Mentor Ophthalmics, I…