FDA 510(k)

CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET

K-Number: K813084 · 1981-12-31

Decision Date1981-12-31

Product CodeKOB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813084. 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 CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET?

CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K813084.

When did CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET receive FDA 510(k) clearance?

CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813084.

Who is the listed applicant for CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET?

The FDA 510(k) record lists Burron Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET?

The FDA product code for CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET is KOB.

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Other records listing Burron Medical Products, Inc. as applicant

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Related Devices (Code: KOB)

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook Incorporated K182709One-Step Suprapubic IntroducerCook Incorporated K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated K120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, Incorporated K014002ALL 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.