Cleared Traditional

K880543 - UNI-PORT

K880543 is an FDA 510(k) clearance for UNI-PORT, manufactured by Surgeon Surgical Instrumentation, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K880543 · Surgeon Surgical Instrumentation, Inc. · Ophthalmic device
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Jul 1988
Decision
143d
Days
Class 1
Risk

K880543 is an FDA 510(k) clearance for the UNI-PORT. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Surgeon Surgical Instrumentation, Inc. (Placentia, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Surgeon Surgical Instrumentation, Inc. devices

FDA 510(k) Submission Details - K880543

510(k) Number K880543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date July 01, 1988
Days to Decision 143 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 110d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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 - KYG Device, Irrigation, Ocular Surgery

All 23
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K880543.
MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS
K922996 · Chiron Vision Corp. · Jul 1992
AQUEOUS PARACENTESIS PIPET
K915808 · Visitec Co. · Mar 1992
SITE DIAPHRAGM CASSETTE
K904186 · Site Microsurgical Systems, Inc. · Nov 1990
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · Staar Surgical Co. · Apr 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · Ameritek, Inc. · Mar 1986