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FDA 510(k)

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE

K-Number: K011105 · 2001-05-30

ApplicantQrc Consulting
Decision Date2001-05-30
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Qrc Consulting. It received FDA 510(k) clearance on 2001-05-30 under 510(k) number K011105. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE?

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is Qrc Consulting. The 510(k) number is K011105.

When did SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE receive FDA 510(k) clearance?

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE received FDA 510(k) clearance on 2001-05-30, under 510(k) number K011105.

Who is the listed applicant for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE?

The FDA 510(k) record lists Qrc Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE?

The FDA product code for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE is GAL.

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Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC

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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