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FDA 510(k)

SUPRAPUBIC FLOW CONTROLLER

K-Number: K904798 · 1991-11-22

ApplicantOlympus Corp.
Decision Date1991-11-22
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUPRAPUBIC FLOW CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K904798. 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 SUPRAPUBIC FLOW CONTROLLER?

SUPRAPUBIC FLOW CONTROLLER is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Olympus Corp.. The 510(k) number is K904798.

When did SUPRAPUBIC FLOW CONTROLLER receive FDA 510(k) clearance?

SUPRAPUBIC FLOW CONTROLLER received FDA 510(k) clearance on 1991-11-22, under 510(k) number K904798.

Who is the listed applicant for SUPRAPUBIC FLOW CONTROLLER?

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

What is the FDA product code for SUPRAPUBIC FLOW CONTROLLER?

The FDA product code for SUPRAPUBIC FLOW CONTROLLER is KOB.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument Corp.

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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