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FDA 510(k)

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET

K-Number: K091441 · 2009-10-30

ApplicantSynergetics, Inc.
Decision Date2009-10-30
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K091441. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET?

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Synergetics, Inc.. The 510(k) number is K091441.

When did SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET receive FDA 510(k) clearance?

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET received FDA 510(k) clearance on 2009-10-30, under 510(k) number K091441.

Who is the listed applicant for SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET?

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

What is the FDA product code for SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET?

The FDA product code for SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET is FRN.

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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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