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FDA 510(k)

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

K-Number: K014002 · 2002-03-04

ApplicantFortune Medical Instrument Corp.
Decision Date2002-03-04
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 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 2002-03-04 under 510(k) number K014002. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890?

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 is a medical device that received FDA 510(k) clearance on 2002-03-04. The listed applicant is Fortune Medical Instrument Corp.. The 510(k) number is K014002.

When did ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 receive FDA 510(k) clearance?

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 received FDA 510(k) clearance on 2002-03-04, under 510(k) number K014002.

Who is the listed applicant for ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890?

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 SUPRA-PUBIA CATHETER, MODELS 4880/4890?

The FDA product code for ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 is KOB.

Related Clinical Trials

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.

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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 #1300K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865K980917ALL 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: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK012153LOWSLEY SUPRAPUBIC TRACTORCircon Video

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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