Cleared Traditional

STORZ E9040 & E9046 DIAMOND KNIVES (K855050) - FDA 510(k) Clearance

Class I Ophthalmic device.

K855050 · Storz Instrument Co. · Ophthalmic device
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Mar 1986
Decision
78d
Days
Class 1
Risk

K855050 is an FDA 510(k) clearance for the STORZ E9040 & E9046 DIAMOND KNIVES. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on March 5, 1986 after a review of 78 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 Storz Instrument Co. devices

Submission Details

510(k) Number K855050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date March 05, 1986
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · This submission: 78d
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

Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K855050.
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
K844553 · Codman & Shurtleff, Inc. · Dec 1984
MICROSURGICAL KNIFE
K841951 · Ethicon, Inc. · Jun 1984
TOME'S #'S 1221,1222,1223,1314,6640,6642
K791980 · Edward Weck, Inc. · Oct 1979
SWAN KNIFE NEEDLE 1.5MM CAT # 1170
K791981 · Edward Weck, Inc. · Oct 1979
MICROSURGICAL KNIVES, 20, 30, 45
K781465 · Codman & Shurtleff, Inc. · Sep 1978