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FDA 510(k)

MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT

K-Number: K070405 · 2007-10-17

ApplicantCook Biotech, Inc.
Decision Date2007-10-17
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2007-10-17 under 510(k) number K070405. 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 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT?

MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT is a medical device that received FDA 510(k) clearance on 2007-10-17. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K070405.

When did MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT receive FDA 510(k) clearance?

MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT received FDA 510(k) clearance on 2007-10-17, under 510(k) number K070405.

Who is the listed applicant for MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT?

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

What is the FDA product code for MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT?

The FDA product code for MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT is FTM.

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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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