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FDA 510(k)

STERILE FOLEY CATHETERS & UROLOGICAL

K-Number: K831743 · 1983-09-12

ApplicantElectromedics, Inc.
Decision Date1983-09-12
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE FOLEY CATHETERS & UROLOGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831743. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE FOLEY CATHETERS & UROLOGICAL?

STERILE FOLEY CATHETERS & UROLOGICAL is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Electromedics, Inc.. The 510(k) number is K831743.

When did STERILE FOLEY CATHETERS & UROLOGICAL receive FDA 510(k) clearance?

STERILE FOLEY CATHETERS & UROLOGICAL received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831743.

Who is the listed applicant for STERILE FOLEY CATHETERS & UROLOGICAL?

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

What is the FDA product code for STERILE FOLEY CATHETERS & UROLOGICAL?

The FDA product code for STERILE FOLEY CATHETERS & UROLOGICAL is KOD.

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Other records listing Electromedics, Inc. as applicant

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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