Cleared Traditional

K163698 - OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

K163698 is an FDA 510(k) clearance for OptiFix Open Absorbable Fixation System..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K163698 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
103d
Days
Class 2
Risk

K163698 is an FDA 510(k) clearance for the OptiFix Open Absorbable Fixation System - 20 absorbable fasteners. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on April 11, 2017 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K163698

510(k) Number K163698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2016
Decision Date April 11, 2017
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 273
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K163698.
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
K162707 · Golden Stapler Surgical Co., Ltd. · Jul 2017
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
K170278 · C.R. Bard, Inc. · May 2017
ECHELON CIRCULAR Powered Stapler
K163523 · Ethicon Endo-Surgery, LLC · Apr 2017
Disposable End-to-end Anastomosis Circular Stapler
K162947 · Chongqing Qmi Surgical Co., Ltd. · Mar 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien · Mar 2017
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
K162710 · Tgs Medical Co., Ltd. · Feb 2017