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FDA 510(k)

STEERABLE STYLET

K-Number: K040001 · 2004-03-09

ApplicantSynovis Surgical Innovations
Decision Date2004-03-09
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEERABLE STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Surgical Innovations. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K040001. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEERABLE STYLET?

STEERABLE STYLET is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Synovis Surgical Innovations. The 510(k) number is K040001.

When did STEERABLE STYLET receive FDA 510(k) clearance?

STEERABLE STYLET received FDA 510(k) clearance on 2004-03-09, under 510(k) number K040001.

Who is the listed applicant for STEERABLE STYLET?

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

What is the FDA product code for STEERABLE STYLET?

The FDA product code for STEERABLE STYLET is DRB.

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Other records listing Synovis Surgical Innovations 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.

K122306SYNOVIS COLLAGEN MATRIX (TBD)K083039VERITAS COLLAGEN MATRIX (DRY)K062915VERITAS COLLAGEN MATRIXK041669VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSDK040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENTK040119PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION

View all 8 devices →

Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K191469Biotronik StyletsBiotronik, Inc.K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook IncorporatedK090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078St Jude MedicalK080924MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi

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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