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FDA 510(k)

SURGISIS, SURGISIS ES

K-Number: K062696 · 2006-10-13

ApplicantCook Biotech, Inc.
Decision Date2006-10-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS, SURGISIS ES 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 2006-10-13 under 510(k) number K062696. 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, SURGISIS ES?

SURGISIS, SURGISIS ES is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K062696.

When did SURGISIS, SURGISIS ES receive FDA 510(k) clearance?

SURGISIS, SURGISIS ES received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062696.

Who is the listed applicant for SURGISIS, SURGISIS ES?

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, SURGISIS ES?

The FDA product code for SURGISIS, SURGISIS ES 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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