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FDA 510(k)

SEXTON CYSTOTOMY URINE PUMP

K-Number: K843158 · 1984-10-04

ApplicantHolter-Hausner Intl.
Decision Date1984-10-04
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SEXTON CYSTOTOMY URINE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K843158. 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 SEXTON CYSTOTOMY URINE PUMP?

SEXTON CYSTOTOMY URINE PUMP is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K843158.

When did SEXTON CYSTOTOMY URINE PUMP receive FDA 510(k) clearance?

SEXTON CYSTOTOMY URINE PUMP received FDA 510(k) clearance on 1984-10-04, under 510(k) number K843158.

Who is the listed applicant for SEXTON CYSTOTOMY URINE PUMP?

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

What is the FDA product code for SEXTON CYSTOTOMY URINE PUMP?

The FDA product code for SEXTON CYSTOTOMY URINE PUMP is KOB.

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Other records listing Holter-Hausner Intl. as applicant

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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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