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FDA 510(k)

RUSCH FLONEIL; FLOCATH INTROGEL

K-Number: K020714 · 2002-07-01

ApplicantRusch Intl.
Decision Date2002-07-01
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUSCH FLONEIL; FLOCATH INTROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K020714. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH FLONEIL; FLOCATH INTROGEL?

RUSCH FLONEIL; FLOCATH INTROGEL is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Rusch Intl.. The 510(k) number is K020714.

When did RUSCH FLONEIL; FLOCATH INTROGEL receive FDA 510(k) clearance?

RUSCH FLONEIL; FLOCATH INTROGEL received FDA 510(k) clearance on 2002-07-01, under 510(k) number K020714.

Who is the listed applicant for RUSCH FLONEIL; FLOCATH INTROGEL?

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

What is the FDA product code for RUSCH FLONEIL; FLOCATH INTROGEL?

The FDA product code for RUSCH FLONEIL; FLOCATH INTROGEL is GBM.

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Other records listing Rusch Intl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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Related Devices (Code: GBM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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