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FDA 510(k)

SIS HERNIA REPAIR DEVICE

K-Number: K974540 · 1998-05-20

ApplicantSentron Medical, Inc.
Decision Date1998-05-20
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIS HERNIA REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sentron Medical, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K974540. 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 SIS HERNIA REPAIR DEVICE?

SIS HERNIA REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Sentron Medical, Inc.. The 510(k) number is K974540.

When did SIS HERNIA REPAIR DEVICE receive FDA 510(k) clearance?

SIS HERNIA REPAIR DEVICE received FDA 510(k) clearance on 1998-05-20, under 510(k) number K974540.

Who is the listed applicant for SIS HERNIA REPAIR DEVICE?

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

What is the FDA product code for SIS HERNIA REPAIR DEVICE?

The FDA product code for SIS HERNIA REPAIR DEVICE is FTL.

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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