Cleared Traditional

K863665 - THE ULTIMATE

K863665 is an FDA 510(k) clearance for THE ULTIMATE, manufactured by Myocure, Inc.. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K863665 · Myocure, Inc. · Ophthalmic device
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Sep 1986
Decision
7d
Days
Class 1
Risk

K863665 is an FDA 510(k) clearance for the THE ULTIMATE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Myocure, Inc. (Glendale, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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.

View all Myocure, Inc. devices

FDA 510(k) Submission Details - K863665

510(k) Number K863665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date September 25, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 110d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNN Knife, Ophthalmic

All 23
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K863665.
MVR/STILETTO BLADE 20GA. - P/N 1900
K881669 · Advanced Surgical Products, Inc. · May 1988
PRISMA DISPOSABLE MVR/STILETTO BLADE
K874979 · Advanced Surgical Products, Inc. · Apr 1988
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · Keeler Instruments, Inc. · Dec 1986
SAPPHIRE KNIFE BLADE
K861744 · Keeler Instruments, Inc. · Jun 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · Keeler Instruments, Inc. · Jun 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · Storz Instrument Co. · May 1986