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FDA 510(k)

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

K-Number: K021142 · 2002-10-01

ApplicantFortune Medical Instrument Corp.
Decision Date2002-10-01
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 is the device name listed in this FDA 510(k) record. The listed applicant is Fortune Medical Instrument Corp.. It received FDA 510(k) clearance on 2002-10-01 under 510(k) number K021142. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865?

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 is a medical device that received FDA 510(k) clearance on 2002-10-01. The listed applicant is Fortune Medical Instrument Corp.. The 510(k) number is K021142.

When did ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 receive FDA 510(k) clearance?

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 received FDA 510(k) clearance on 2002-10-01, under 510(k) number K021142.

Who is the listed applicant for ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865?

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

What is the FDA product code for ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865?

The FDA product code for ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 is EZL.

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Other records listing Fortune Medical Instrument Corp. 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.

K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIRK980919ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.

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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