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FDA 510(k)

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

K-Number: K082828 · 2008-10-14

ApplicantSuturtek Incorporated
Decision Date2008-10-14
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Suturtek Incorporated. It received FDA 510(k) clearance on 2008-10-14 under 510(k) number K082828. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE?

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2008-10-14. The listed applicant is Suturtek Incorporated. The 510(k) number is K082828.

When did SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE receive FDA 510(k) clearance?

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE received FDA 510(k) clearance on 2008-10-14, under 510(k) number K082828.

Who is the listed applicant for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE?

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

What is the FDA product code for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE?

The FDA product code for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE is GAQ.

Related Clinical Trials

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.

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Other records listing Suturtek Incorporated as applicant

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.

K063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17K032468SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICEK030227SUTURTEK FASTCLOSE SUTURING DEVICE

Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated

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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