Cleared Traditional

K834546 - SURGICAL KNIFE

K834546 is the FDA 510(k) clearance for SURGICAL KNIFE by Fine-Cut Diamond Instruments. It is a Class 1 Ophthalmic device (product code HNN) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K834546 · Fine-Cut Diamond Instruments · Ophthalmic device
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Mar 1984
Decision
80d
Days
Class 1
Risk

K834546 is an FDA 510(k) clearance for the SURGICAL KNIFE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Fine-Cut Diamond Instruments (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 80 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 Fine-Cut Diamond Instruments devices

Submission Details

510(k) Number K834546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1983
Decision Date March 16, 1984
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 22
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K834546.
CATARACT TRAY
K842647 · Deroyal Industries, Inc. · May 1985
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · Codman & Shurtleff, Inc. · Dec 1984
MICROSURGICAL KNIFE
K841951 · Ethicon, Inc. · Jun 1984
RUBY KNIVES FOR OPHTH. SURGERY
K832844 · Keeler Instruments, Inc. · Sep 1983
MICROSURGERY KNIFE
K820618 · Visitec Co. · Apr 1982
PILLING K KNIFE
K812918 · Narco Scientific · Nov 1981