Cleared Traditional

K120827 - QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)

K120827 is an FDA 510(k) clearance for QUILL PDO KNOTLESS TISSUE-CLOSURE DEVIC..., manufactured by Angiotech. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K120827 · Angiotech · General & Plastic Surgery device
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Jul 2012
Decision
116d
Days
Class 2
Risk

K120827 is an FDA 510(k) clearance for the QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE). Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Angiotech (Reading, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 116 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.

View all Angiotech devices

FDA 510(k) Submission Details - K120827

510(k) Number K120827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date July 13, 2012
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 54
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K120827.
MINT
K130191 · Hans Biomed Corporation · Jun 2013
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
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
K113744 · Angiotech · Feb 2012
PDS(TM) BARBED SUTURES
K113004 · Ethicon, Inc. · Dec 2011