Cleared Traditional

K111382 - CELVER

K111382 · Cellulose Concepts, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
380d
Days
-
Risk

K111382 is an FDA 510(k) clearance for the CELVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Cellulose Concepts, LLC (Great Neck, US). The FDA issued a Cleared decision on May 31, 2012 after a review of 380 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K111382

510(k) Number K111382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2011
Decision Date May 31, 2012
Days to Decision 380 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
265d slower than avg
Panel avg: 115d · This submission: 380d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K111382.
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
K121275 · Convatec, Inc. · Jul 2012
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K121522 · Polyremedy, Inc. · Jun 2012
MANUKA IG
K120976 · Links Medical Products, Inc. · May 2012
MANUKA FILL
K121227 · Links Medical Products, Inc. · May 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K112549 · Covalontechnologies, Inc. · May 2012
K111382 · CELVER
Download PDF FDA Summary Cellulose Concepts, L…