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FDA 510(k)

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

K-Number: K013059 · 2001-10-22

ApplicantStony Brook Surgical Innovations, Inc.
Decision Date2001-10-22
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) is the device name listed in this FDA 510(k) record. The listed applicant is Stony Brook Surgical Innovations, Inc.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K013059. 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 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)?

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Stony Brook Surgical Innovations, Inc.. The 510(k) number is K013059.

When did STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) receive FDA 510(k) clearance?

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) received FDA 510(k) clearance on 2001-10-22, under 510(k) number K013059.

Who is the listed applicant for STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)?

The FDA 510(k) record lists Stony Brook Surgical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)?

The FDA product code for STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) 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 Stony Brook Surgical Innovations, Inc. 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.

K930015STERNAL BAND

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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