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FDA 510(k)

SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL

K-Number: K982475 · 1998-09-22

ApplicantTissue Technologies, Inc.
Decision Date1998-09-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Technologies, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982475. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL?

SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Tissue Technologies, Inc.. The 510(k) number is K982475.

When did SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL receive FDA 510(k) clearance?

SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982475.

Who is the listed applicant for SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL?

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

What is the FDA product code for SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL?

The FDA product code for SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL is FTL.

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Other records listing Tissue Technologies, 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.

K002071SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLESK000849SOFTFORM FACIAL IMPLANTK973462SOFTFORM FACIAL IMPLANTK970804TRU-PULSE CO2 SURGICAL LASERK963683TRU-PULSE LASER (MODIFIED)K962496SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)

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Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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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