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FDA 510(k)

CATHETERIZATION SYS. URINARY DRAINAGE

K-Number: K771779 · 1977-10-05

ApplicantMedical Devices, Inc.
Decision Date1977-10-05
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETERIZATION SYS. URINARY DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1977-10-05 under 510(k) number K771779. 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 CATHETERIZATION SYS. URINARY DRAINAGE?

CATHETERIZATION SYS. URINARY DRAINAGE is a medical device that received FDA 510(k) clearance on 1977-10-05. The listed applicant is Medical Devices, Inc.. The 510(k) number is K771779.

When did CATHETERIZATION SYS. URINARY DRAINAGE receive FDA 510(k) clearance?

CATHETERIZATION SYS. URINARY DRAINAGE received FDA 510(k) clearance on 1977-10-05, under 510(k) number K771779.

Who is the listed applicant for CATHETERIZATION SYS. URINARY DRAINAGE?

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

What is the FDA product code for CATHETERIZATION SYS. URINARY DRAINAGE?

The FDA product code for CATHETERIZATION SYS. URINARY DRAINAGE is KOD.

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Other records listing Medical Devices, Inc. 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.

K002280PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATE

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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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