Cleared Special

K172538 - Disposable Linear Stapler, Disposable Linear Cutter (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172538 · Changzhou Kangdi Medical Stapler Co., Ltd. · General & Plastic Surgery device
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Nov 2017
Decision
100d
Days
Class 2
Risk

K172538 is an FDA 510(k) clearance for the Disposable Linear Stapler, Disposable Linear Cutter. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Kangdi Medical Stapler Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on November 30, 2017 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Changzhou Kangdi Medical Stapler Co., Ltd. devices

Submission Details

510(k) Number K172538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2017
Decision Date November 30, 2017
Days to Decision 100 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 114d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 281
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