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FDA 510(k)

SURGISIS RVP RECTO-VAGINAL FISTULA PLUG

K-Number: K062729 · 2006-10-10

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

Device Summary

SURGISIS RVP RECTO-VAGINAL FISTULA PLUG 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 2006-10-10 under 510(k) number K062729. 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 RVP RECTO-VAGINAL FISTULA PLUG?

SURGISIS RVP RECTO-VAGINAL FISTULA PLUG is a medical device that received FDA 510(k) clearance on 2006-10-10. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K062729.

When did SURGISIS RVP RECTO-VAGINAL FISTULA PLUG receive FDA 510(k) clearance?

SURGISIS RVP RECTO-VAGINAL FISTULA PLUG received FDA 510(k) clearance on 2006-10-10, under 510(k) number K062729.

Who is the listed applicant for SURGISIS RVP RECTO-VAGINAL FISTULA PLUG?

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 RVP RECTO-VAGINAL FISTULA PLUG?

The FDA product code for SURGISIS RVP RECTO-VAGINAL FISTULA PLUG 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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