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FDA 510(k)

OPUS SMARTSTITCH SUTURE DEVICE

K-Number: K070671 · 2007-04-06

ApplicantArthrocare Corp.
Decision Date2007-04-06
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPUS SMARTSTITCH SUTURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2007-04-06 under 510(k) number K070671. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS SMARTSTITCH SUTURE DEVICE?

OPUS SMARTSTITCH SUTURE DEVICE is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Arthrocare Corp.. The 510(k) number is K070671.

When did OPUS SMARTSTITCH SUTURE DEVICE receive FDA 510(k) clearance?

OPUS SMARTSTITCH SUTURE DEVICE received FDA 510(k) clearance on 2007-04-06, under 510(k) number K070671.

Who is the listed applicant for OPUS SMARTSTITCH SUTURE DEVICE?

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

What is the FDA product code for OPUS SMARTSTITCH SUTURE DEVICE?

The FDA product code for OPUS SMARTSTITCH SUTURE DEVICE is OCW.

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Other records listing Arthrocare Corp. as applicant

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Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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