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FDA 510(k)

2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH

K-Number: K913841 · 1991-10-08

ApplicantEndovations
Decision Date1991-10-08
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH is the device name listed in this FDA 510(k) record. The listed applicant is Endovations. It received FDA 510(k) clearance on 1991-10-08 under 510(k) number K913841. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH?

2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH is a medical device that received FDA 510(k) clearance on 1991-10-08. The listed applicant is Endovations. The 510(k) number is K913841.

When did 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH receive FDA 510(k) clearance?

2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH received FDA 510(k) clearance on 1991-10-08, under 510(k) number K913841.

Who is the listed applicant for 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH?

The FDA 510(k) record lists Endovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH?

The FDA product code for 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH is FGE.

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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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