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FDA 510(k)

OPTIMIZED BARB DESIGN

K-Number: K052962 · 2005-12-06

ApplicantSurgical Specialties Corp
Decision Date2005-12-06
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTIMIZED BARB DESIGN is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. It received FDA 510(k) clearance on 2005-12-06 under 510(k) number K052962. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMIZED BARB DESIGN?

OPTIMIZED BARB DESIGN is a medical device that received FDA 510(k) clearance on 2005-12-06. The listed applicant is Surgical Specialties Corp. The 510(k) number is K052962.

When did OPTIMIZED BARB DESIGN receive FDA 510(k) clearance?

OPTIMIZED BARB DESIGN received FDA 510(k) clearance on 2005-12-06, under 510(k) number K052962.

Who is the listed applicant for OPTIMIZED BARB DESIGN?

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

What is the FDA product code for OPTIMIZED BARB DESIGN?

The FDA product code for OPTIMIZED BARB DESIGN is GAW.

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Other records listing Surgical Specialties Corp 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.

K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONEK071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIALK072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMK063680SHARPOINT PDO (POLYDIOXANONE) SUTURESK053380CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, 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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