Cleared Traditional

K153611 - Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device

K153611 is an FDA 510(k) clearance for Coated VICRYU (Polyglactin 91O)Sterile ..., manufactured by Ethicon, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K153611 · Ethicon, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
169d
Days
Class 2
Risk

K153611 is an FDA 510(k) clearance for the Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridge.... Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Ethicon, LLC (Los Frailes Industrial Park, Suite 401, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 169 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 - K153611

510(k) Number K153611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date June 03, 2016
Days to Decision 169 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
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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

Ethicon Endo-Surgery, Inc.
Rubina Dosani

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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 148
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K153611.
CRYLREX
K161629 · Sm Eng Co., Ltd. · Feb 2017
TroClose1200
K160564 · Gordian Surgical, Ltd. · Nov 2016
E-Pack Procedure Kit
K161726 · Ethicon, Inc. · Jul 2016
PGA RESORBA, PGA RESOQUICK, GLYCOLON
K143584 · Resorba Medical GmbH · Nov 2015
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · M/s. Meril Endo Surgery Private Limited. · Oct 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
K153611 · Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Download PDF FDA Summary Ethicon, LLC