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FDA 510(k)

UNI-PORT

K-Number: K880543 · 1988-07-01

ApplicantSurgeon Surgical Instrumentation, Inc.
Decision Date1988-07-01
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNI-PORT is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K880543. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-PORT?

UNI-PORT is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K880543.

When did UNI-PORT receive FDA 510(k) clearance?

UNI-PORT received FDA 510(k) clearance on 1988-07-01, under 510(k) number K880543.

Who is the listed applicant for UNI-PORT?

The FDA 510(k) record lists Surgeon Surgical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNI-PORT?

The FDA product code for UNI-PORT is KYG.

Other records listing Surgeon Surgical Instrumentation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954241SURGIN GENISIS PHACOEMULSIFIERK932281VERRES NEEDLEK922038CO2 INSUFFLATION TUBINGK904010SURGICAL ASPIRATOR KITK890447HEMORRHAGE OCCLUDORK881232SURGIN EYE SHIELD

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Related Devices (Code: KYG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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