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FDA 510(k)

SURGISIS STAPLE LINE REINFORCEMENT II

K-Number: K051048 · 2005-09-23

ApplicantCook Biotech, Inc.
Decision Date2005-09-23
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS STAPLE LINE REINFORCEMENT II 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 2005-09-23 under 510(k) number K051048. 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 SURGISIS STAPLE LINE REINFORCEMENT II?

SURGISIS STAPLE LINE REINFORCEMENT II is a medical device that received FDA 510(k) clearance on 2005-09-23. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K051048.

When did SURGISIS STAPLE LINE REINFORCEMENT II receive FDA 510(k) clearance?

SURGISIS STAPLE LINE REINFORCEMENT II received FDA 510(k) clearance on 2005-09-23, under 510(k) number K051048.

Who is the listed applicant for SURGISIS STAPLE LINE REINFORCEMENT II?

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 SURGISIS STAPLE LINE REINFORCEMENT II?

The FDA product code for SURGISIS STAPLE LINE REINFORCEMENT II is 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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