ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K-Number: K213633 · 2022-04-08
ApplicantEthicon Endo-Surgery, LLC
Decision Date2022-04-08
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2022-04-08 under approval number K213633. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K213633.
When was ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler approved by the FDA?
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler received FDA 510(k) clearance on 2022-04-08, under approval number K213633.
What company makes ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is manufactured by Ethicon Endo-Surgery, LLC.
What is the FDA product code for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?
The FDA product code for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is GAG.
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K241629ECHELON 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)Ethicon Endo-Surgery, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.