FDA 510(k)

EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS

K-Number: K091211 · 2009-09-04

Decision Date2009-09-04

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Sugery, LLC. It received FDA 510(k) clearance on 2009-09-04 under 510(k) number K091211. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS?

EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS is a medical device that received FDA 510(k) clearance on 2009-09-04. The listed applicant is Ethicon Endo-Sugery, LLC. The 510(k) number is K091211.

When did EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS receive FDA 510(k) clearance?

EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS received FDA 510(k) clearance on 2009-09-04, under 510(k) number K091211.

Who is the listed applicant for EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS?

The FDA 510(k) record lists Ethicon Endo-Sugery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS?

The FDA product code for EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS is GCJ.

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Other records listing Ethicon Endo-Sugery, LLC as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.