Cleared Traditional

K150032 - GluStitch Twist Tissue Adhesive

K150032 is an FDA 510(k) clearance for GluStitch Twist Tissue Adhesive, manufactured by Glustitch, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K150032 · Glustitch, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
371d
Days
Class 2
Risk

K150032 is an FDA 510(k) clearance for the GluStitch Twist Tissue Adhesive. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Glustitch, Inc. (Delta, CA). The FDA issued a Cleared decision on January 14, 2016 after a review of 371 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: 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 - K150032

510(k) Number K150032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2015
Decision Date January 14, 2016
Days to Decision 371 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
256d slower than avg
Panel avg: 115d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPN Device Classification - Class 2, Special Controls

Product Code MPN Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4010
Definition Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Regulatory and Clinical Research Institute, Inc.
TIM ROBINSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MPN Tissue Adhesive For The Topical Approximation Of Skin

All 35
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K150032.
SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
K161011 · Adhezion Biomedical, LLC · Nov 2016
ACTABOND Topical Skin Adhesive
K161050 · Bergen Medical Products, Inc. · Oct 2016
Exofin High Viscosity Tissue Adhesive
K152476 · Chemence Medical Products, Inc. · Feb 2016
BONDEASE TOPICAL SKIN ADHESIVE
K141157 · Optmed, Inc. · Dec 2015
LiquiBand Exceed
K151182 · Advanced Medical Solutions (Plymouth), Ltd. · Oct 2015
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
K152096 · Ethicon, Inc. · Oct 2015