Cleared Traditional

K213633 - ECHELON 3000 45mm Stapler

K213633 is the FDA 510(k) clearance for ECHELON 3000 45mm Stapler by Ethicon Endo-Surgery, LLC. It is a Class 2 General & Plastic Surgery device (product code GAG) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K213633 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Apr 2022
Decision
142d
Days
Class 2
Risk

K213633 is an FDA 510(k) clearance for the ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler. Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on April 8, 2022 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - 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.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K213633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2021
Decision Date April 08, 2022
Days to Decision 142 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 slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
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 - GAG Stapler, Surgical

All 29
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K213633.
TA™ Stapler and Loading Unit with DST Series™ Technology
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EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
K232126 · Covidien · Aug 2023
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
K221629 · Covidien · Feb 2023
PROXIMATE DISPOSABLE SKIN STAPLER
K970079 · Ethicon Endo-Surgery, Inc. · Mar 1997
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc. · Sep 1996
DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
K934188 · Deroyal Industries, Inc. · Mar 1994