Cleared Traditional

K193652 - AbClose - Port Site Closure Device

K193652 is the FDA 510(k) clearance for AbClose - Port Site Closure Device by Medeon Biodesign, Inc.. It is a Class 2 General & Plastic Surgery device (product code OCW) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K193652 · Medeon Biodesign, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2020
Decision
87d
Days
Class 2
Risk

K193652 is an FDA 510(k) clearance for the AbClose - Port Site Closure Device. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Medeon Biodesign, Inc. (Taipei, TW). The FDA issued a Cleared decision on March 26, 2020 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medeon Biodesign, Inc. devices

Submission Details

510(k) Number K193652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date March 26, 2020
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 Peers - OCW Endoscopic Tissue Approximation Device

All 36
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K193652.
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