Cleared Traditional

K101769 - EPISIL

K101769 · Camurus AB · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
446d
Days
-
Risk

K101769 is an FDA 510(k) clearance for the EPISIL. Classified as Oral Wound Dressing (product code OLR).

Submitted by Camurus AB (North Reading, US). The FDA issued a Cleared decision on September 13, 2011 after a review of 446 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 - K101769

510(k) Number K101769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2010
Decision Date September 13, 2011
Days to Decision 446 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 115d · This submission: 446d
Pathway characteristics
Predicate-based equivalence.

OLR Device Classification - Class 0,

Product Code OLR Oral Wound Dressing
Device Class -
Definition Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq.

Regulatory Peers - OLR Oral Wound Dressing

All 42
Devices cleared under the same product code (OLR) and FDA review panel - the closest regulatory comparables to K101769.
SUNTOUCH Dental Dressing
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AFTAMED MOUTHWASH
K130959 · Bioplax Limited · Apr 2014
AONGEN DENTAL COLLAGEN MATRIX
K112568 · Aeon Astron Europe B.V. · Mar 2012
PERIOPATCH
K110750 · Mis Implants Technologies , Ltd. · Apr 2011
PERIOPATCH
K103054 · Izun Pharmaceuticals Corporation · Feb 2011
BENACEL
K090612 · Unicare Biomedical · Jul 2009
K101769 · EPISIL
Download PDF FDA Summary Camurus AB