Cleared Traditional

K171561 - Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload

K171561 is an FDA 510(k) clearance for Dextera MicroCutter 30 Blue Reload, manufactured by Dextera Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K171561 · Dextera Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
90d
Days
Class 2
Risk

K171561 is an FDA 510(k) clearance for the Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Re.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Dextera Surgical, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 28, 2017 after a review of 90 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.

FDA 510(k) Submission Details - K171561

510(k) Number K171561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2017
Decision Date August 28, 2017
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 276
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K171561.
Disposable Circular Stapler
K172561 · Changzhou Kangdi Medical Stapler Co., Ltd. · Dec 2017
Disposable Linear Stapler, Disposable Linear Cutter
K172538 · Changzhou Kangdi Medical Stapler Co., Ltd. · Nov 2017
AEON Endoscopic Stapler
K171589 · Lexington Medical, Inc. · Nov 2017
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
K171561 · Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
Download PDF FDA Summary Dextera Surgical, Inc.