Cleared Traditional

K240185 - Cypris eXact Suture Placement Device (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K240185 · Cypris Medical · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
101d
Days
Class 1
Risk

K240185 is an FDA 510(k) clearance for the Cypris eXact Suture Placement Device. Classified as Carrier, Ligature (product code GEJ), Class I - General Controls.

Submitted by Cypris Medical (Chicago, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K240185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2024
Decision Date May 03, 2024
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 114d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEJ Carrier, Ligature
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.