Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMARTSTITCH SUTURE DEVICE, MODEL OM-8500

K-Number: K022229 · 2002-09-06

ApplicantOpus Medical, Inc.
Decision Date2002-09-06
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMARTSTITCH SUTURE DEVICE, MODEL 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 2002-09-06 under 510(k) number K022229. 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 SMARTSTITCH SUTURE DEVICE, MODEL OM-8500?

SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Opus Medical, Inc.. The 510(k) number is K022229.

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

SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 received FDA 510(k) clearance on 2002-09-06, under 510(k) number K022229.

Who is the listed applicant for SMARTSTITCH SUTURE DEVICE, MODEL 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 SMARTSTITCH SUTURE DEVICE, MODEL OM-8500?

The FDA product code for SMARTSTITCH SUTURE DEVICE, MODEL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-9070K030170REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500

View all 13 devices →

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.

↑