Cleared Traditional

K151081 - MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge

K151081 is an FDA 510(k) clearance for MicroCutter XCHANGE 30 Stapler, manufactured by Cardica, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K151081 · Cardica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
268d
Days
Class 2
Risk

K151081 is an FDA 510(k) clearance for the MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroC.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Cardica, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 15, 2016 after a review of 268 days - an extended review cycle.

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 - K151081

510(k) Number K151081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2015
Decision Date January 15, 2016
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 Consultant

Domecus Consulting Services, LLC
Cindy Domecus

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 - GDW Staple, Implantable

All 273
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K151081.
Signia Stapler
K160176 · Covidien · Apr 2016
iMESH Tacker
K153202 · Thd Lap · Mar 2016
ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm
K160521 · Ethicon Endo-Surgery, LLC · Mar 2016
PANTHER Cutter Stapler
K152618 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Nov 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
K151659 · Covidien, LLC · Jul 2015
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
K142577 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Jun 2015