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FDA 510(k)

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS

K-Number: K905229 · 1991-01-18

ApplicantArrow Intl., Inc.
Decision Date1991-01-18
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K905229. 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 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS?

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K905229.

When did LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS receive FDA 510(k) clearance?

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS received FDA 510(k) clearance on 1991-01-18, under 510(k) number K905229.

Who is the listed applicant for LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS?

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

What is the FDA product code for LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS?

The FDA product code for LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS is FGE.

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Related Devices (Code: 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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