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FDA 510(k)

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021

K-Number: K092821 · 2010-02-01

ApplicantAgency For Medical Innovations, Inc.
Decision Date2010-02-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations, Inc.. It received FDA 510(k) clearance on 2010-02-01 under 510(k) number K092821. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021?

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 is a medical device that received FDA 510(k) clearance on 2010-02-01. The listed applicant is Agency For Medical Innovations, Inc.. The 510(k) number is K092821.

When did TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 receive FDA 510(k) clearance?

TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 received FDA 510(k) clearance on 2010-02-01, under 510(k) number K092821.

Who is the listed applicant for TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021?

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

What is the FDA product code for TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021?

The FDA product code for TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 is GCJ.

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Related Devices (Code: GCJ)

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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.

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