Cleared Traditional

K182476 - Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182476 · Fengh Medical Co., Ltd. · General & Plastic Surgery device
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Dec 2019
Decision
464d
Days
Class 2
Risk

K182476 is an FDA 510(k) clearance for the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Fengh Medical Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on December 18, 2019 after a review of 464 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Fengh Medical Co., Ltd. devices

Submission Details

510(k) Number K182476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date December 18, 2019
Days to Decision 464 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 114d · This submission: 464d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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