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Found 3 results
510(k) Data Aggregation
(84 days)
The Laurus Medical Curvilinear Suture Placement System is indicated for the placement of suture in a variety of Transvaginal procedures such as prolapse repair, cystourethropexy, and bladder neck stabilization; through Cooper's Ligament alone and/or in conjunction with non-device suturing procedures for the correction of urinary stress incontinence: for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Curvilinear Suture Placement Device
I am sorry, but the provided text does not contain the information you requested about acceptance criteria and study details for the Curvilinear Suture Placement Device. The document is a 1997 FDA 510(k) clearance letter confirming that the device is substantially equivalent to previously marketed devices. It primarily focuses on regulatory approval and does not include details about device performance studies, acceptance criteria, sample sizes, or ground truth establishment.
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(71 days)
The Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.
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I am sorry, but without text from the document describing the acceptance criteria or a study related to device performance, I cannot provide the requested information. The provided text only contains a letter from the FDA regarding a 510(k) submission for a Stereotactic Needle Core Biopsy Device, indicating its clearance for marketing and its intended use. It does not include any details about acceptance criteria, study design, or performance metrics.
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(52 days)
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