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FDA 510(k)

NELATON-, FEMALE - OR TIEMANN CATHETER

K-Number: K896729 · 1990-11-05

ApplicantUnoplast A/S
Decision Date1990-11-05
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NELATON-, FEMALE - OR TIEMANN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Unoplast A/S. It received FDA 510(k) clearance on 1990-11-05 under 510(k) number K896729. 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 NELATON-, FEMALE - OR TIEMANN CATHETER?

NELATON-, FEMALE - OR TIEMANN CATHETER is a medical device that received FDA 510(k) clearance on 1990-11-05. The listed applicant is Unoplast A/S. The 510(k) number is K896729.

When did NELATON-, FEMALE - OR TIEMANN CATHETER receive FDA 510(k) clearance?

NELATON-, FEMALE - OR TIEMANN CATHETER received FDA 510(k) clearance on 1990-11-05, under 510(k) number K896729.

Who is the listed applicant for NELATON-, FEMALE - OR TIEMANN CATHETER?

The FDA 510(k) record lists Unoplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NELATON-, FEMALE - OR TIEMANN CATHETER?

The FDA product code for NELATON-, FEMALE - OR TIEMANN CATHETER is KOD.

Related Clinical Trials

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.

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Other records listing Unoplast A/S 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.

K896734FEEDING TUBEK896732UNOMETER 500K896730SUCTION CATHETER STRAIGHT/COUDEK896731OXYGEN CATHETERSK896733VACCONK802248DISARP ORIGINAL

View all 7 devices →

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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