FDA 510(k)

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025

K-Number: K003036 · 2000-12-22

Decision Date2000-12-22

Product CodeKYG

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 is the device name listed in this FDA 510(k) record. The listed applicant is Retinalabs.Com. It received FDA 510(k) clearance on 2000-12-22 under 510(k) number K003036. 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 TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025?

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 is a medical device that received FDA 510(k) clearance on 2000-12-22. The listed applicant is Retinalabs.Com. The 510(k) number is K003036.

When did TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 receive FDA 510(k) clearance?

TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 received FDA 510(k) clearance on 2000-12-22, under 510(k) number K003036.

Who is the listed applicant for TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025?

The FDA 510(k) record lists Retinalabs.Com as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025?

The FDA product code for TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 is KYG.

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Other records listing Retinalabs.Com as applicant

K000418PDT DOSECALCULATOR, MODEL 80000 K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

Related Devices (Code: KYG)

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Official Source

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