Cleared Traditional

K101114 - ADVANCIS ACTIVON TUBE

K101114 · Advancis Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
461d
Days
-
Risk

K101114 is an FDA 510(k) clearance for the ADVANCIS ACTIVON TUBE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advancis Medical (Kirby In Ashfield, GB). The FDA issued a Cleared decision on July 26, 2011 after a review of 461 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.

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FDA 510(k) Submission Details - K101114

510(k) Number K101114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2010
Decision Date July 26, 2011
Days to Decision 461 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
346d slower than avg
Panel avg: 115d · This submission: 461d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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