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FDA 510(k)

HORIZONS ERCP CANNULA

K-Number: K002235 · 2001-01-23

ApplicantHorizons Intl. Corp.
Decision Date2001-01-23
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HORIZONS ERCP CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Horizons Intl. Corp.. It received FDA 510(k) clearance on 2001-01-23 under 510(k) number K002235. 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 HORIZONS ERCP CANNULA?

HORIZONS ERCP CANNULA is a medical device that received FDA 510(k) clearance on 2001-01-23. The listed applicant is Horizons Intl. Corp.. The 510(k) number is K002235.

When did HORIZONS ERCP CANNULA receive FDA 510(k) clearance?

HORIZONS ERCP CANNULA received FDA 510(k) clearance on 2001-01-23, under 510(k) number K002235.

Who is the listed applicant for HORIZONS ERCP CANNULA?

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

What is the FDA product code for HORIZONS ERCP CANNULA?

The FDA product code for HORIZONS ERCP CANNULA is FGE.

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Other records listing Horizons Intl. Corp. as applicant

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K083049TORNADO ROTATABEL SNARE AND POLYP CATCHERK022243HORIZONS REUSABLE HOT BIOPSY FORCEPSK022268HORIZONS REUSABLE POLYPECTOMY SNARESK022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLESK021998HORIZONS CYTOLOGY BRUSHK021706HORIZONS HOT BIOPSY FORCEPS

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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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