Cleared Traditional

K945575 - PRO BARRIER(TM) TUBE SOX(TM)

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

FDA 510(k) Submission Details - K945575

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.

MMN Device Classification - Class ,

Product Code MMN
Device Class -