Cleared Special

K131966 - TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM (FDA 510(k) Clearance)

K131966 · Twin Star Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
224d
Days
-
Risk

K131966 is an FDA 510(k) clearance for the TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETE.... Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Twin Star Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Twin Star Medical, Inc. devices

Submission Details

510(k) Number K131966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date February 07, 2014
Days to Decision 224 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -