Cleared Traditional

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed (K181653) - FDA 510(k) Clearance

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

K181653 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Sep 2018
Decision
88d
Days
Class 2
Risk

K181653 is an FDA 510(k) clearance for the Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on September 18, 2018 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K181653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date September 18, 2018
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 130
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K181653.
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