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FDA 510(k)

ECHELON ENDOPATH Staple Line Reinforcement

K-Number: K221343 · 2022-09-16

ApplicantEthicon Endo-Surgery, LLC
Decision Date2022-09-16
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHELON ENDOPATH Staple Line Reinforcement is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2022-09-16 under approval number K221343. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON ENDOPATH Staple Line Reinforcement?

ECHELON ENDOPATH Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K221343.

When was ECHELON ENDOPATH Staple Line Reinforcement approved by the FDA?

ECHELON ENDOPATH Staple Line Reinforcement received FDA 510(k) clearance on 2022-09-16, under approval number K221343.

What company makes ECHELON ENDOPATH Staple Line Reinforcement?

ECHELON ENDOPATH Staple Line Reinforcement is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for ECHELON ENDOPATH Staple Line Reinforcement?

The FDA product code for ECHELON ENDOPATH Staple Line Reinforcement is OXC.

Related Clinical Trials

NCT07339020 Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve Gastrectomy COMPLETED

Other Devices by Ethicon Endo-Surgery, LLC

K160554Enseal X1 Large Jaw Tissue Sealer K160128Endopath Electrosurgery Probe Plus II K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm K151136HARMONIC HOOK K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length K163523ECHELON CIRCULAR Powered Stapler

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Related Devices (Code: OXC)

K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc. K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC K221487NEOVEIL Staple Line ReinforcementGunze Limited K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc. K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)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.

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