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FDA 510(k)

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

K-Number: K030170 · 2003-07-28

ApplicantOpus Medical, Inc.
Decision Date2003-07-28
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 is the device name listed in this FDA 510(k) record. The listed applicant is Opus Medical, Inc.. It received FDA 510(k) clearance on 2003-07-28 under 510(k) number K030170. 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 REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500?

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 is a medical device that received FDA 510(k) clearance on 2003-07-28. The listed applicant is Opus Medical, Inc.. The 510(k) number is K030170.

When did REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 receive FDA 510(k) clearance?

REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 received FDA 510(k) clearance on 2003-07-28, under 510(k) number K030170.

Who is the listed applicant for REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500?

The FDA 510(k) record lists Opus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500?

The FDA product code for REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 is OCW.

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 Opus Medical, 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.

K042584OPUS MINIMAGNUM ANCHOR WITH INSERTERK042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042031OPUS SPEEDSTITCH SUTURE DEVICEK041440OPUS MAGNUM ANCHOR WITH INSERTERK033317SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070K031083OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500

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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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