K141157 is an FDA 510(k) clearance for the BONDEASE TOPICAL SKIN ADHESIVE. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.
Submitted by Optmed, Inc. (New York, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 596 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4010 - the FDA general and plastic surgery device framework. 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.
View all Optmed, Inc. devices
NCT01716013
Completed
Interventional
Industry-sponsored
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
A Multi-Center, Prospective, Open-label, Randomized Study of the Safety and Efficacy of BondEase™ Topical Skin Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions
| Condition studied |
Traumatic Lacerations or Surgical Incisions |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
OptMed, Inc.
(industry)
|
Started 2012-09-01
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Primary completion 2014-01-01
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Completed 2014-02-01
Primary outcome
100% Wound Apposition at 10 Days
Secondary outcome
Optimal Cosmetic Outcome at 28 Days (Score of 6)
View full study on ClinicalTrials.gov