Cleared Traditional

K053613 - L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE

K053613 · Theo Manufacturing BV · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
575d
Days
-
Risk

K053613 is an FDA 510(k) clearance for the L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Theo Manufacturing BV (Bailey, US). The FDA issued a Cleared decision on July 25, 2007 after a review of 575 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K053613

510(k) Number K053613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date July 25, 2007
Days to Decision 575 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
460d slower than avg
Panel avg: 115d · This submission: 575d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
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