Cleared Traditional

K120284 - DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

K120284 is an FDA 510(k) clearance for DIGITEX SUTURE DELIVERY SYSTEM, manufactured by Coloplast A/S. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K120284 · Coloplast A/S · 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
113d
Days
Class 2
Risk

K120284 is an FDA 510(k) clearance for the DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0,.... Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on May 23, 2012 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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. Standard predicate reliance. 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 - K120284

510(k) Number K120284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date May 23, 2012
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 66
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K120284.
ORTHOCORD
K123668 · Depuy Mitek, Inc., A Johnson and Johnson Company · Feb 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123877 · Surgical Specialties Corp. Dba Angiotech · Jan 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
K120827 · Angiotech · Jul 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
K113744 · Angiotech · Feb 2012
PDS(TM) BARBED SUTURES
K113004 · Ethicon, Inc. · Dec 2011
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
K100780 · Unilene Sac · Dec 2010
K120284 · DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
Download PDF FDA Summary Coloplast A/S