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FDA 510(k)

FORTAFLEX SURGICAL SLING

K-Number: K021107 · 2002-05-15

ApplicantOrganogenesis, Inc.
Decision Date2002-05-15
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FORTAFLEX SURGICAL SLING is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2002-05-15 under 510(k) number K021107. 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 FORTAFLEX SURGICAL SLING?

FORTAFLEX SURGICAL SLING is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is Organogenesis, Inc.. The 510(k) number is K021107.

When did FORTAFLEX SURGICAL SLING receive FDA 510(k) clearance?

FORTAFLEX SURGICAL SLING received FDA 510(k) clearance on 2002-05-15, under 510(k) number K021107.

Who is the listed applicant for FORTAFLEX SURGICAL SLING?

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

What is the FDA product code for FORTAFLEX SURGICAL SLING?

The FDA product code for FORTAFLEX SURGICAL SLING is FTM.

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Other records listing Organogenesis, Inc. as applicant

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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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