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FDA 510(k)

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

K-Number: K032468 · 2003-09-23

ApplicantSuturtek Incorporated
Decision Date2003-09-23
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURTEK FASTCLOSE STERNUM 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 2003-09-23 under 510(k) number K032468. 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 FASTCLOSE STERNUM CLOSURE DEVICE?

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Suturtek Incorporated. The 510(k) number is K032468.

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

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE received FDA 510(k) clearance on 2003-09-23, under 510(k) number K032468.

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

The FDA product code for SUTURTEK FASTCLOSE STERNUM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICEK063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17K030227SUTURTEK 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, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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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