Cleared Special

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

K241629 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery
Jul 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K241629 is an FDA 510(k) clearance for the ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L), a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, PR). The FDA issued a Cleared decision on July 3, 2024, 27 days after receiving the submission on June 6, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.

Submission Details

510(k) Number K241629 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2024
Decision Date July 03, 2024
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAG — Stapler, Surgical
Device Class Class II — 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.

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