FDA 510(k)

ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

K-Number: K080972 · 2008-07-03

Decision Date2008-07-03

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP 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 2008-07-03 under 510(k) number K080972. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP?

ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP is a medical device that received FDA 510(k) clearance on 2008-07-03. The listed applicant is Ethicon Endo-Sugery, LLC. The 510(k) number is K080972.

When did ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP receive FDA 510(k) clearance?

ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP received FDA 510(k) clearance on 2008-07-03, under 510(k) number K080972.

Who is the listed applicant for ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP?

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 ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP?

The FDA product code for ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP is GDW.

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Other records listing Ethicon Endo-Sugery, LLC as applicant

K112033ENSEAL G2 TISSUS SEALERS K101990ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11 K110699LIGAMAX 5 K091211EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS K082278MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS

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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.