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FDA 510(k)

SURGIMEND

K-Number: K083898 · 2009-02-04

ApplicantTei Biosciences, Inc.
Decision Date2009-02-04
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGIMEND is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K083898. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIMEND?

SURGIMEND is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K083898.

When did SURGIMEND receive FDA 510(k) clearance?

SURGIMEND received FDA 510(k) clearance on 2009-02-04, under 510(k) number K083898.

Who is the listed applicant for SURGIMEND?

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

What is the FDA product code for SURGIMEND?

The FDA product code for SURGIMEND is FTM.

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Other records listing Tei Biosciences, 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.

K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionK153690PriMatrix Dermal Repair ScaffoldK131286PRIMATRIX DERMAL REPAIR SCAFFOLDK100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDK083440PRIMATRIX DERMAL REPAIR SCAFFOLDK071807ORTHOMEND SOFT TISSUE MATRIX

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Related Devices (Code: FTM)

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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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