Cleared Traditional

PRO BARRIER(TM) TUBE SOX(TM) (K945575) - FDA 510(k) Clearance

K945575 · Cottrell, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
112d
Days
-
Risk

K945575 is an FDA 510(k) clearance for the PRO BARRIER(TM) TUBE SOX(TM).

Submitted by Cottrell, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel. 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cottrell, Ltd. devices

Submission Details

510(k) Number K945575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date March 06, 1995
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMN
Device Class -