Cleared Traditional

K851768 - 13-550

K851768 is an FDA 510(k) clearance for 13-550, manufactured by Artiberia. The device is a Class 1 Ophthalmic device with product code HNF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K851768 · Artiberia · Ophthalmic device
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Jun 1985
Decision
56d
Days
Class 1
Risk

K851768 is an FDA 510(k) clearance for the 13-550,13-560 WESCOTT SCOSSORS (EYE). Classified as Scissors, Ophthalmic (product code HNF), Class I - General Controls.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 56 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 Artiberia devices

FDA 510(k) Submission Details - K851768

510(k) Number K851768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1985
Decision Date June 20, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
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 8
Devices cleared under the same product code (HNF) and FDA review panel - the closest regulatory comparables to K851768.
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K873099 · Alcon Laboratories · Sep 1987
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, MICRO IRIS STRAIGHT
K760185 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976
SCISSORS, MICRO IRIS CURVED
K760188 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976