Cleared Traditional

K897093 - INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.

K897093 is an FDA 510(k) clearance for INTRAOCULAR MICROSCISSORS BY MEANS OF G..., manufactured by Microline Pentax, Inc.. The device is a Class 1 Ophthalmic device with product code HNF cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K897093 · Microline Pentax, Inc. · Ophthalmic device
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Apr 1990
Decision
105d
Days
Class 1
Risk

K897093 is an FDA 510(k) clearance for the INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.. Classified as Scissors, Ophthalmic (product code HNF), Class I - General Controls.

Submitted by Microline Pentax, Inc. (Devers, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Microline Pentax, Inc. devices

FDA 510(k) Submission Details - K897093

510(k) Number K897093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date April 04, 1990
Days to Decision 105 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 110d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

HNF Device Classification - Class 1, General Controls

Product Code HNF Scissors, 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 - HNF Scissors, Ophthalmic

All 12
Devices cleared under the same product code (HNF) and FDA review panel - the closest regulatory comparables to K897093.
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K873099 · Alcon Laboratories · Sep 1987
13-550,13-560 WESCOTT SCOSSORS (EYE)
K851768 · Artiberia · Jun 1985
IRIS SCISSORS STRAIGHT 4 1/2
K821286 · Conphar, Inc. · May 1982
LITTAUER SCISSORS 5 1/2
K821290 · Conphar, Inc. · May 1982
OPHTHALMIC SCISSORS
K811245 · Keeler Instruments, Inc. · Jul 1981
SCISSORS, STRABIMUS, 4 STRAIGHT
K770040 · J. Sklar Mfg. Co., Inc. · Jan 1977