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FDA 510(k)

FREEDOM INGUINAL HERNIA IMPLANT

K-Number: K113552 · 2012-08-23

ApplicantInsightra Medical
Decision Date2012-08-23
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FREEDOM INGUINAL HERNIA IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Insightra Medical. It received FDA 510(k) clearance on 2012-08-23 under 510(k) number K113552. 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 FREEDOM INGUINAL HERNIA IMPLANT?

FREEDOM INGUINAL HERNIA IMPLANT is a medical device that received FDA 510(k) clearance on 2012-08-23. The listed applicant is Insightra Medical. The 510(k) number is K113552.

When did FREEDOM INGUINAL HERNIA IMPLANT receive FDA 510(k) clearance?

FREEDOM INGUINAL HERNIA IMPLANT received FDA 510(k) clearance on 2012-08-23, under 510(k) number K113552.

Who is the listed applicant for FREEDOM INGUINAL HERNIA IMPLANT?

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

What is the FDA product code for FREEDOM INGUINAL HERNIA IMPLANT?

The FDA product code for FREEDOM INGUINAL HERNIA IMPLANT is FTL.

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Related Devices (Code: FTL)

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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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