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FDA 510(k)

TT-102

K-Number: K081246 · 2009-08-13

ApplicantTissue Technologies Holdings, LLC
Decision Date2009-08-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TT-102 is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Technologies Holdings, LLC. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K081246. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TT-102?

TT-102 is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Tissue Technologies Holdings, LLC. The 510(k) number is K081246.

When did TT-102 receive FDA 510(k) clearance?

TT-102 received FDA 510(k) clearance on 2009-08-13, under 510(k) number K081246.

Who is the listed applicant for TT-102?

The FDA 510(k) record lists Tissue Technologies Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TT-102?

The FDA product code for TT-102 is FRO. This falls under the Anesthesiology category.

Other records listing Tissue Technologies Holdings, LLC 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.

K061060TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8

Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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